[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asthma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,240,0,25,[9,47,77,102,132,158,184,211,238,270,292,312,334,356,380,399,422,442,465,490,513,531,553,577,597],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054316","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qmf149-indacaterol-acetatemometasone-furoate-versus-budesonide-in-children-from-6-to-less-than-12-years-of-age-with-asthma-100054316",false,"NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","ALL","6 Years","11 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[28],"Asthma",[28,30,31,32,33],"Pediatric","Breezhaler","QMF149","Budesonide","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2023-05-11",{"date":42,"type":22},"2028-05-30",{"name":44,"class":45},"Novartis Pharmaceuticals","INDUSTRY",63,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100591353","phase-3-depemokimab-asthma-imaging-and-bronchoscopy-sub-study-100591353","NCT06979323","Depemokimab Asthma Imaging and Bronchoscopy Sub-Study","The IMAGINE Study: A Phase 3b Open Label, Single Arm Study to Assess the Effect of Depemokimab on Airway Structure and Function in Asthma With Type 2 Inflammation Characterized by an Eosinophilic Phenotype Utilizing Quantitative High-resolution CT and Bronchoscopic Airway Sampling in a Sub Study","Inclusion Criteria:\n\n* Documented clinical diagnosis of asthma for greater than or equal to (\\>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines (GINA, 2024), or joint guidance from the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network \\[NICE, 2024\\] along with the following: an eosinophilic phenotype as evidenced by a blood eosinophil count of \\>=300 cells\u002Fmicroliters (mcL) at screening or a documented history of blood eosinophil count \\>=300 cells\u002FmcL within 3 months prior to screening; Exhaled nitric oxide (FeNO) measure of \\>=25 parts per billion (ppb) recorded at screening; and a previously confirmed history of \\>= 2 exacerbations requiring treatment with systemic corticosteroid (SCS; intramuscular \\[IM\\], intravenous \\[IV\\], or oral), in the 12 months prior to screening, despite the use of medium to high dose Inhaled corticosteroids (ICS)\n* Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (\\>) 1.5 recorded at screening\n* Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (\\\u003C) 80 percentage (%) predicted (GLI 2012) and recorded at screening\n* A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance oral corticosteroids \\[OCS\\])\n* Current treatment with at least one additional asthma controller medication, besides ICS, for at least 3 months \\[for example, Long-acting Beta 2 agonists \\[LABA\\], Long-acting muscarinic antagonists \\[LAMA\\], leukotriene receptor antagonist (LTRA), or theophylline\\]\n* Male Participants: No additional requirements for male participants\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a participant of non-childbearing potential (PONCBP) or is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency,\n* A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n* Capable of giving written informed consent,\n* For the bronchoscopy sub study participants who sign the Informed Consent for the biopsy sub study, the following additional eligibility criteria will apply:\n\n  * Participants not on maintenance OCS (oral corticosteroids) at the time of screening.\n  * Participants with post bronchodilator FEV1 \\>= 50% predicted\n  * Participants with no known increased risk for bleeding or clotting abnormalities including: No history of easy bleeding, bruising or known bleeding diathesis; No current anticoagulant and antiplatelet therapy; No acetylsalicylic acid use within 2 weeks of the planned procedure; Normal screening platelet count\n  * Participants with no specific contraindication to bronchoscopy with endobronchial biopsy in the opinion of the investigator\n  * No history of allergic reaction to local anesthesia or general anesthetic agent, whichever is relevant to the procedure being performed\n\nExclusion Criteria:\n\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic obstructive pulmonary disease \\[COPD\\] other than asthma) are excluded\n* Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis\n* Participants who developed an exacerbation within 4 weeks before screening\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved\n* A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening\n* Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic abnormalities or any other system abnormalities that are uncontrolled with standard treatment\n* Participants with current diagnosis of vasculitis\n* Participants who have a previous documented failure with anti-IL-5\u002F5R therapy\n* Participants who have received monoclonal antibody (mAb) therapy targeting IL 5\u002F5R, IL 4R\u002FIL 13, IL 33, IgE, or Thymic Stromal Lymphpoietin (TSLP) within 12 months or 5 terminal phase half-lives of the drug, whichever is longer prior to the screening. Authorized treatments for Coronavirus disease-2019 (COVID-19) are permitted\n* Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to the first dose of study intervention (this also includes investigational formulations of marketed products)\n* Previously participated in any clinical study with biologic treatments for asthma (for example, omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, other mAbs (including Tezepelumab) or depemokimab and received study intervention (including placebo) within 12 months prior to the first dose of study intervention\n* A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention\n* Current smokers or former smokers with a smoking history \\>=20 pack years (number of pack years = \\[number of cigarettes per day\u002F20\\] x number of years smoked) and vapers\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of depemokimab\n* Participants who are pregnant or breastfeeding\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations\n* Participants who have occupational ionizing-radiation exposure exceeding 10 Millisievert (mSV) over 3 years as documented with a dosimeter; have been exposed to elevated ionizing radiation from research imaging studies, for example, Participation in a research study with a single positron emission tomography scan in the past 3 years, and Participation in a research study with 2 or more computed tomography (CT) scans in the past 3 years in the following anatomical regions: chest, abdomen, cardiac, or spine\n* Presence of metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis\n* Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator","18 Years",{"count":56,"type":22},150,[25],"Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\\\\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.",[28],[61,28,62,63,64,65,66],"Depemokimab","Type 2 Inflammation","Eosinophilic Phenotype","High Resolution Computed Tomography (HRCT)","Bronchoscopy","IMAGINE study","2026-07-01",{"date":69,"type":38},"2026-07-02",{"date":71,"type":38},"2024-07-19",{"date":73,"type":22},"2028-02-11",{"name":75,"class":45},"GlaxoSmithKline",50,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":54,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100528312","smarthome-feasibility-trial-100528312","NCT06159127","SMART@Home Feasibility Trial","Self-Management Assistance for Recommended Treatment (SMART)@Home Care","Inclusion Criteria:\n\n* Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma\n* Ages 12-18\n* English fluency for patient and caregiver\n\nExclusion Criteria:\n\n* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review","12 Years",{"count":7,"type":22},[87],"NA","The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.\n\nResults from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.\n\nA beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.",[28,90],"Asthma in Children",[28],"2026-06-30",{"date":69,"type":38},{"date":95,"type":38},"2024-09-09",{"date":97,"type":22},"2027-07-31",{"name":99,"class":100},"Children's Hospital Medical Center, Cincinnati","OTHER",1,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":101},"100644099","phase-4-novel-method-for-removal-of-orally-deposited-inhaled-fluticasone-propionate-100644099","NCT07664527","Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate","A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma","EVOOW","Inclusion Criteria:\n\n* Healthy adults and adults with asthma, age 18 years and older\n* Willing to hold orally and nasally inhaled corticosteroids (ICS) for 24h and 12h, respectively, before study visits with mouthwash sample collections (Visit 2 and Visit 3)\n* No systemic or topical ocular corticosteroid use for the prior 4 weeks.\n\nExclusion Criteria:\n\n* Known hypersensitivity to fluticasone propionate\n* Allergy to olives or olive oil\n* Known allergy to oxymetazoline\n* Current smoking or vaping\n* Currently pregnant or trying to become pregnant.",true,{"count":112,"type":22},20,[114],"PHASE4","This study is to find out if an Extra Virgin Olive-Oil-based Water (EVOOW) mix, removes more Fluticasone Propionate (FP) from the mouth than Water alone. 2 strengths of the EVOOW mix will be tested, one with equal parts EVOO and Water (50\u002F50) and one with 3 parts EVOO and 1 part Water (75\u002F25). Removing more FP deposits may help decrease the risk for obstructive sleep apnea (OSA), candidiasis (thrush), and speech and swallow dysfunction. Participants will be on study for up to 3 weeks.",[28],[118,119,120,121,122],"Fluticasone Propionate","EVOO","upper airway","oral deposits","inhaler","NOT_YET_RECRUITING","2026-06-29",{"date":67,"type":38},{"date":127,"type":22},"2026-07",{"date":129,"type":22},"2027-04",{"name":131,"class":100},"University of Wisconsin, Madison",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":157},"100526542","protocol-cause-03--cheetah-100526542","NCT06136091","Protocol CAUSE-03 \u002F CHEETAH","Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)","CHEETAH","Inclusion Criteria:\n\n1. Participant and\u002For parent guardian must be able to understand and provide informed consent and assent\n2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP)\n\n   a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion\n3. Either:\n\n   1. Have had a diagnosis of asthma made \\> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \\\u003C= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or\n   2. No report of ever being diagnosed with asthma (non-asthma group)\n4. Either:\n\n   1. Require at least Step 2 therapy at the Screening\u002FEnrollment Visit (asthma group), or\n   2. Have not used any asthma medications in the prior year (non-asthma group)\n5. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment\n6. Have documentation of current medical insurance with prescription coverage at the Screening\u002FEnrollment Visit\n7. Participant and\u002For parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use\n\nExclusion Criteria:\n\n1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol\n2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study\n3. Are currently receiving immunotherapy\n4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment\n5. Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and\u002For individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening\u002FEnrollment Visit\n6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception)\n7. Have a known, pre-existing clinically important lung condition other than asthma.\n8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment\n9. Have a known immunodeficiency disease\n10. Use of investigational drugs within 4 weeks of enrollment\n11. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n12. If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH\n13. If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \\> = 10%) at the Screening\u002FEnrollment visit\n14. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)","17 Years",{"count":142,"type":22},310,"OBSERVATIONAL","This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old.\n\nParticipants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits",[28],[28,147,148],"Observational study","Children",{"date":67,"type":38},{"date":151,"type":38},"2024-05-08",{"date":153,"type":22},"2027-09-01",{"name":155,"class":156},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",8,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":110,"sex":17,"minAge":54,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":4,"leadSponsor":181,"locationsCount":183},"100083273","personalized-environment-and-genes-study-100083273","NCT00341237","Personalized Environment and Genes Study","* INCLUSION CRITERIA\n\nIn order to be eligible for participation in this study, an individual must meet all of the following criteria:\n\n* Adults greater than or equal to 18 years of age\n* If female, must not be (self-reported as) pregnant. At the time of enrollment, a pregnancy test will only be done at the PI s discretion.\n* Able to understand and provide written informed consent\n* Able to come to the NIEHS Clinical Research Unit (CRU) for enrollment and study-related visits\u002Fprocedures.\n\nEXCLUSION CRITERIA\n\nAn individual who does not meet the inclusion criteria listed above is excluded from participation in this study.","120 Years",{"count":166,"type":22},25000,"Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us.\n\nThe Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and\u002For any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project.\n\nTo expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies.\n\nWhole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.",[169,170,28],"Diabetes","Heart Disease",[172,173,174,175,176],"Genotype","Phenotype","Environmental Factor","Single Nucleotide Polymorphism","Natural History","2026-06-27",{"date":92,"type":38},{"date":180,"type":38},"2010-05-26",{"name":182,"class":156},"National Institute of Environmental Health Sciences (NIEHS)",2,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100644137","phase-4-betri-prospective-asthma-control-in-single-inhaler-icslabalama-8759-pmdi-bdpffgb---1006125-g-vs-single-inhaler-icslaba-2006-pmdi-bdpff---2006-g-100644137","NCT07666490","BETRI-Prospective: Asthma Control in Single Inhaler ICS\u002FLABA\u002FLAMA (87\u002F5\u002F9 pMDI [BDP\u002FFF\u002FGB - 100\u002F6\u002F12.5 μg]) vs Single Inhaler ICS\u002FLABA (200\u002F6 pMDI [BDP\u002FFF - 200\u002F6 μg])","A Pragmatic, Phase IV, Randomized, Open-label, Multinational, Multicentre, 2-arm Parallel Group, Prospective Study Comparing Efficacy and Safety of Single Inhaler ICS\u002FLABA\u002FLAMA (Beclometasone\u002FFormoterol Fumarate\u002FGlycopyrronium Bromide [87\u002F5\u002F9 pMDI { BD\u002FFF\u002FGB -100\u002F6\u002F12.5 μg} ]) vs Single Inhaler ICS\u002FLABA (Beclometasone Dipropionate Plus Formoterol Fumarate [200\u002F6 pMDI { BD\u002FFF - 200\u002F6 μg} ]) in Asthma Subjects","BETRI","Inclusion Criteria:\n\n1 . Study participant's written informed consent obtained prior to any study related procedure.\n\n2\\. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.\n\n4\\. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS\u002FLABA regular treatment.\n\n5\\. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).\n\n6\\. Women with childbearing potential (WOCBP) and with fertile male partners: they and\u002For their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.\n\n7\\. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved.\n\nNote: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg\u002Fday of beclometasone or equivalent.\n\nExclusion Criteria: The presence of any of the following will exclude a study participant from study enrolment:\n\n1. Participation in another interventional clinical trial.\n2. Pregnant or breastfeeding women at the moment of enrolment.\n3. Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled\u002Fclinically significant diseases (according to investigator's judgement).\n4. Contraindication for LAMA use.\n5. Study participants on biological therapies for asthma.\n6. For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study (Country\u002FRegion-Specific Differences - France), in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code.",{"count":193,"type":22},644,[114],"This study will evaluate the effect of triple ICS\u002FLAMA\u002FLABA therapy with a BDP\u002FFF\u002FGB 100\u002F6\u002F12.5 µg on asthma control outcomes relative to ICS\u002FLABA therapy with BDP\u002FFF 200\u002F6 μg in a population with asthma poorly controlled.",[28],[198,199,200,201,202],"asthma control","adults","pragmatic study","BDP\u002FFF\u002FGB","BDP\u002FFF","2026-06-25",{"date":124,"type":38},{"date":206,"type":22},"2026-06-12",{"date":208,"type":22},"2028-06-13",{"name":210,"class":45},"Chiesi Farmaceutici S.p.A.",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":219,"maxAge":19,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100517903","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-tezepelumab-compared-with-placebo-in-children-5-to--12-years-old-with-severe-asthma-100517903","NCT06023589","A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to \u003C 12 Years Old With Severe Asthma","A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to \u003C 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)","HORIZON","Inclusion Criteria:\n\n1. Written informed consent from (ICF) at least one parent\u002Fcaregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.\n2. Participants must be 5 to \\\u003C 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.\n3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.\n4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.\n5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.\n6. Supportive evidence of asthma as documented by one of the following:\n\n   1. Post-BD (albuterol\u002Fsalbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol\u002Fsalbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.\n\n      If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:\n   2. Post-BD responsiveness of FEV1 ≥ 10%.\n   3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg\u002FmL.\n   4. PEF average daily diurnal variability \\> 13% over a 2-week period.\n   5. Variability of FEV1 ≥ 12% between any two clinical visits.\n   6. Positive exercise challenge test (defined as a fall in FEV1 of \\> 12%).\n   7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.\n7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.\n8. Pre-BD FEV1 \\>50% and ≤ 95%PN OR FEV1\u002Fforced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.\n9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:\n\n   1. ACQ-IA score ≥ 1.5 at least once during Screening\u002FRun-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.\n   2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening\u002FRun-in period.\n   3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening\u002FRun-in period.\n   4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening\u002FRun-in period.\n10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).\n\nExclusion Criteria:\n\n1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.\n2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.\n4. Change in ICS dose within 1 month prior to Visit 1.\n5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.","5 Years",{"count":221,"type":22},231,[25],"To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.",[28],[28,226,227,228],"Uncontrolled Asthma","Severe Uncontrolled Asthma","Human monoclonal antibody (IgG2λ) cytokine",{"date":230,"type":38},"2026-06-26",{"date":232,"type":38},"2023-08-24",{"date":234,"type":22},"2030-08-23",{"name":236,"class":45},"AstraZeneca",143,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":110,"sex":17,"minAge":54,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":101},"100641361","phase-1-a-study-to-learn-how-different-amounts-of-the-study-medicine-called-pf-08103402-are-tolerated-and-act-in-the-body-in-healthy-adults-or-adults-with-mild-to-moderate-asthma-100641361","NCT07660731","A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma","A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, RELATIVE BIOAVAILABILITY, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND\u002FOR ADULTS WITH MILD TO MODERATE ASTHMA","Key Inclusion criteria (Parts A, B, C, D and F):\n\n1. Are males or females who can no longer have children,\n2. Are 18 to 65 years old,\n3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nFor Part A (Optional group or cohort 3: Japanese participants only):\n\n1. A total body weight of more than 45 kg (100 pounds).\n2. Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\nAdults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.\n\n1\\. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nKey Exclusion criteria\n\n1. Evidence or history of clinically significant medical conditions.\n2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).\n3. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 6 months of Screening.\n4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.\n5. Any history of parasitic infection requiring treatment within 28 days prior to screening.\n6. Positive tuberculosis infection test result.\n7. Part C only: Evidence or history of conditions interfering with the ability to taste.\n8. Part D only: History of irregular bowel movements.\n9. Part E only: Evidence of lung disease(s) other than asthma.\n10. Part E only: Asthma exacerbation within 3 months prior to screening.\n11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.","65 Years",{"count":247,"type":22},139,[249],"PHASE1","The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.\n\nFor Parts A, B, C, D and F, the study is seeking participants who:\n\n* Are healthy (do not have disease) males or females who can no longer have children,\n* Are 18 to 65 years old,\n* Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight\n\nFor Part A (optional group or cohort 3: Japanese participants only):\n\n* A body weight of more than 45 kilograms (100 pounds).\n* Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\n* Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.\n* Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nThe study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:\n\n* how the body processes the study medicine in healthy participants (Parts A and B),\n* how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),\n* how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),\n* how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),\n* if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).\n\nParticipants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).\n\nDuring this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.\n\nStudy measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure and pulse), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).",[252,253,254,28],"Healthy Volunteer Study","Healthy Adults","Healthy Participants",[256,257,258,259,260,261],"Human","Randomized","Metabolism","Excretion","Drug-Drug Interaction","Food effect","2026-06-24",{"date":124,"type":38},{"date":265,"type":38},"2026-06-17",{"date":267,"type":22},"2027-06-18",{"name":269,"class":45},"Pfizer",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100616140","phase-2-therapeutic-equivalence-of-chf5993-pmdi-1006125-g-hfa-152a-in-subjects-with-mild-to-moderate-asthma-100616140","NCT07301736","Therapeutic Equivalence of CHF5993 pMDI 100\u002F6\u002F12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma","A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100\u002F6\u002F12.5 µg HFA-152a Versus CHF5993 pMDI 100\u002F6\u002F12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma","TRECONY","Inclusion Criteria:\n\n* Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;\n* Non-smokers, ex-smokers;\n* Body mass index: within the range of 18.0 to 35.0 kg\u002Fm2 inclusive;\n* Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:\n\n  1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or\n  2. low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).\n* Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score \\\u003C1.5 at screening and at randomisation.\n* Pre-BD (Bronchodilator) FEV1 \\>40% and \\\u003C90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).\n* A demonstrated increase in either FEV1 or forced vital capacity of \\>12% and \\>200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).\n\nExclusion Criteria:\n\n* History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;\n* Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and\u002For during the run-in period ;\n* Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;\n* Asthma subjects currently treated with any of the following :\n\n  1. High dose ICS;\n  2. Long-acting muscarinic antagonist (LAMA);\n  3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;\n  4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;\n  5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;\n* Respiratory disorders other than asthma\n* Lung resection;\n* Lower respiratory tract infection;\n* Lung cancer and history of lung cancer;\n* Subjects with active cancer or a history of cancer (other than lungs) ;\n* Patients who have clinically significant cardiovascular condition;\n* Run-in compliance: e-Diary completion \\\u003C75% and run-in treatment compliance \\\u003C75% at randomisation;","75 Years",{"count":280,"type":22},780,[282],"PHASE2","This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.",[28],{"date":203,"type":38},{"date":287,"type":38},"2025-12-17",{"date":289,"type":22},"2027-06-03",{"name":210,"class":45},167,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"100567164","phase-3-a-randomized-double-blind-placebo-controlled-trial-on-efficacy-and-safety-of-fluticasone-propionatealbuterol-sulfate-combination-in-participants-12-years-and-older-with-asthma-100567164","NCT06664619","A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate\u002FAlbuterol Sulfate Combination in Participants 12 Years and Older With Asthma","A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate\u002FAlbuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma","Inclusion Criteria:\n\n* The participant has a diagnosis of asthma of at least 6 months duration.\n* Participants currently receive a beta-agonist (eg, salbutamol \\[albuterol\\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication.\n* If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the trial), or is of non-childbearing potential.\n\nNOTE- Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode.\n* The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms of the infection(s) must be completely resolved prior to entering screening.\n* The participant is a current smoker and\u002For has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping\u002F e-cigarettes, hookah\u002Fwaterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded.\n* The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome.\n\nNOTE- Additional criteria apply, please contact the investigator for more information",{"count":300,"type":22},724,[25],"The primary objective of the trial is to evaluate the efficacy of fluticasone propionate\u002Falbuterol sulfate multidose dry powder inhaler with electronic module (Fp\u002FABS eMDPI).\n\nSecondary objectives are:\n\n* To evaluate the efficacy of Fp\u002FABS eMDPI administered four times daily\n* To evaluate the safety and tolerability of Fp\u002FABS eMDPI administered four times daily over four weeks\n* To investigate the pharmacokinetics of Fp\u002FABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose\n\nThe planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.",[28],{"date":203,"type":38},{"date":306,"type":38},"2024-12-12",{"date":308,"type":22},"2026-09-19",{"name":310,"class":45},"Teva Branded Pharmaceutical Products R&D LLC",183,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":330,"leadSponsor":332,"locationsCount":101},"100644848","quantifying-the-burden-of-type-2-t2-inflammation-in-asthma-100644848","NCT07675044","Quantifying the Burden of Type 2 (T2) Inflammation in Asthma","QUANTAS-PC: Quantifying the Burden of Type 2 (T2) Inflammation in Asthma in Primary Care and Community Specialty Practices","QUANTAS","Participant Inclusion Criteria\n\n* Age 18 years and older\n* Ability to consent and comply with protocol assessments\n* Pre-existing diagnosis of asthma and has started treatment\n\nParticipant Exclusion Criteria\n\n* Participant deemed medically ineligible per the opinion of the investigator\n* History of respiratory\u002Flung disease other than asthma (e.g., COPD, emphysema, chronic bronchitis, tuberculosis, cystic fibrosis, lung cancer, recurrent pneumonia or other chronic lung disease)\n* Participants who meet criteria for GINA 5, severe asthma (ICS + additional controllers)\n* Current Enrollment in an asthma intervention trial that could affect asthma outcomes clinically and T2 biomarkers\n* Visit with a specialist (i.e. Pulmonologist or Allergist) in the past year who is measuring FeNO levels",{"count":21,"type":22},"This study is designed to support the assessment of Type 2 (T2) biomarkers in asthma in primary care and community specialty practices. To assess T2 biomarkers, individuals will be required to complete a breath test for fractional exhaled nitric oxide (FeNO) and consent to a review of their medical records. Asthma often goes undetected in primary care and community settings, and through this study the researchers hope to optimize referral pathways to care.",[28,323],"Type 2 Asthma",[28,325,326],"Eosinophils","Exhaled Nitric Oxide","2026-06-23",{"date":92,"type":38},{"date":127,"type":22},{"date":331,"type":22},"2027-05",{"name":333,"class":100},"Icahn School of Medicine at Mount Sinai",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":157},"100628007","phase-3-a-study-of-efficacy-and-safety-of-depemokimab-compared-with-placebo-in-adults-and-adolescents-with-at-risk-type-2-asthma-100628007","NCT07456033","A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma","The MODIFY Study: A Phase 3b\u002F4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks","MODIFY","Inclusion Criteria:\n\n* Adults and adolescents \\>=12 years of age, at the time of signing the informed consent\u002Fassent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \\>=18 years of age.\n* Participants must have a documented physician diagnosis of asthma for \\>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines\n* Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.\n\n  * Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)\u002F Long-acting beta2-adrenergic receptor agonist (LABA).\n* A well-documented requirement for treatment with low to medium dose ICS\u002FLABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy\u002FSingle Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.\n\n  * Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS\u002FLABA.\n* Sex and Contraceptive\u002FBarrier Requirements Male or eligible female Participants:\n\n  * Male Participants: Contraception for male participants with female partners is not required.\n  * Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n  * Is a participant of nonchildbearing potential (PONCBP) OR\n  * Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention.\n  * A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.\n  * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n  * The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Capable of giving signed informed consent\u002Fassent as which includes compliance with the requirements Randomization inclusion criteria-\n* Type 2 high disease at risk of asthma exacerbations as defined by either:\n\n  * An elevated peripheral blood eosinophils (EOS) count of \\>=500 cells\u002Fmilliliter (mL) at screening or \\>=500 cells\u002FmL in the last 3 months prior to the screening visit.\n\nOR\n\n* An elevated peripheral blood EOS count of \\>=300 cells\u002FmL at screening OR \\>=300 cells\u002FmL in the last 3 months prior to the screening visit AND\n\n  * Fractional exhaled nitric oxide \\>=35 parts per billion (ppb) at screening. OR\n  * Documented current Chronic Rhinosinusitis with Nasal Polyps.\n\nExclusion Criteria:\n\n* Participants have had 3 or more exacerbations in the last year prior to Visit 1.\n* Participants on maintenance OCS or high dose ICS\u002FLABA for asthma.\n* Participants with a duration of asthma greater than (\\>)20 years.\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.\n* Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.\n* Participants who developed an exacerbation within 4 weeks before screening.\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.\n* A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma.\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.\n* Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment.\n* Participants with current diagnosis of vasculitis.\n* Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb).\n* A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.\n* Current smokers or former smokers with a smoking history of \\>=20 pack years (number of pack years = \\[number of cigarettes per day\u002F20\\] \\* number of years smoked) and vapers.\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of depemokimab.\n* Participants who are pregnant or breastfeeding.\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations.\n* Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator.\n\nLiver safety exclusion criteria:\n\n* Alanine aminotransferase (ALT) \\>2\\* Upper limit of normal (ULN).\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome: can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5\\*ULN.\n* Cirrhosis or current unstable liver or biliary disease as per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n\nCardiac safety exclusion criteria:\n\n* Electrocardiogram (ECG) Assessment: QTc corrected by Fridericia's formula (QTcF) \\>=450 millisecond (msec) or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12-lead ECG machine read at Visit 1.\n* Participants are excluded if an abnormal ECG finding from central over read of the 12 lead ECG conducted at Screening Visit is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator.\n\nRandomization exclusion criteria:\n\n* ECG Assessment: QTcF \\>=450 msec or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12 lead ECG machine read at Visit 1.\n* ALT \\>2\\*ULN.\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\\u003C=1.5\\*ULN.\n* Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable.\n* Maintenance Asthma Therapy: Any changes in the dose or regimen of baseline ICS and\u002For additional controller medication (except for treatment of an exacerbation) during the run-in period.",{"count":343,"type":22},456,[25],"The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).",[28],[348,61,340,349],"GSK3511294","Type 2 asthma",{"date":203,"type":38},{"date":352,"type":38},"2026-03-13",{"date":354,"type":22},"2030-07-08",{"name":75,"class":45},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":4},"100644513","phase-3-a-study-of-depemokimab-in-participants-of-6-to-11-years-of-age-100644513","NCT07671001","A Study of Depemokimab in Participants of 6 to 11 Years of Age","A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old","GLIDE","Inclusion Criteria:\n\n* Participants who have a documented physician diagnosis of asthma for at least 12 months prior to Visit 1 that meets the National Heart, Lung, and Blood Institute guidelines \\[NHLBI, 2007\\] or Global Initiative of Asthma (GINA) guidelines \\[GINA, 2025\\] or Japanese Pediatric Guidelines for The Treatment and Management of Asthma \\[JPGL, 2023\\]\n* Asthma with type 2 inflammation characterised by an eosinophilic phenotype as indicated by: elevated peripheral blood eosinophil count of greater than or equal to (\\>=)300 cells\u002Fmicroliters (mcL) demonstrated in the past 12 months, or elevated peripheral blood eosinophil count of \\>=150 cells\u002F mcL at visit 1\n* Participants who are \\>=15 Kilograms (kg) in body weight\n* A well-documented requirement for regular treatment with inhaled corticosteroid (\\>=200 mcg\u002Fday fluticasone propionate (DPI) or equivalent daily) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). The Inhaled corticosteroids (ICS) dose should represent medium or high dose in children aged 6-11 years of age\n* Current treatment with an additional controller medication for at least 3 months prior to screening \\[e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline\\]. For Japan only: This inclusion criterion does not apply to the participants in Japan. As long as the ICS dose represent high dose, the current treatment or previous failure of an additional controller will not be required for eligibility\n* Previously confirmed history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (CS) (intramuscular \\[IM\\], intravenous, or oral), in the 12 months prior to visit 1, despite the use of ICS. For participants receiving maintenance OCS, treatment for the exacerbations must have been a two-fold increase or greater in the CS dose\n* Male or eligible female\n* A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: Is prepuberal or having periods but no sexual activity or using an acceptable contraceptive method, if sexual activity. prior to and during the study intervention period (at a minimum until 35 weeks after the last dose of study intervention).\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a girl with an early undetected pregnancy\n* The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant and the participant's assent, when applicable, before any study-specific activity is performed unless a waiver of informed consent has been granted by an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC). All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand\n* A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of activities (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant, as needed\n\nExclusion Criteria:\n\n* Participants with any history of life-threatening asthma (e.g. requiring intubation and assisted ventilation), immunosuppressive medications intake with the exception of oral CS for asthma, or immunodeficiency disorder\n* Or presence of a known pre-existing, clinically important lung condition other than asthma\n* Participants with other conditions that could lead to elevated eosinophils\n* Participants who have known, pre-existing, clinically significant medical conditions that could affect the conduct of the study\n* Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment\n* Participants who have received mepolizumab (Nucala), reslizumab (Cinqair\u002FCinqaero) or benralizumab (Fasenra) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1 or who have previous documented failure with anti- Interleukin-5 Receptor (IL5\u002F5R) therapy\n* Participants who have received omalizumab (e.g., Xolair, Omlyclo), tezepelumab (Tezspire) or dupilumab (Dupixent) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1\n* Participants who have received any monoclonal Antibody (mAb) within 130 days or 5-half-lives (whichever is longer) of Visit 1. Authorised treatments for Coronavirus disease 2019 (COVID-19) are permitted and should be used in line with local regulatory guidance\n* Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products)\n* Participants who have received treatment with an experimental anti-inflammatory drug (non-biologicals) within 3 months prior to Visit 1\n* Concurrent enrollment in another clinical trial\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of the investigational products\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations\n* Liver safety exclusion criteria: Participants who meet the following criteria based on results from the sample taken at Screening Visit\n\n  * Alanine aminotransferase (ALT) greater than (\\>)2 \\* Upper limit of normal (ULN)\n  * Total bilirubin \\>1.5 \\* ULN; for participants with Gilbert's syndrome can be included with total bilirubin \\>1.5xULN as long as direct bilirubin is less than or equal to (=\\\u003C) 1.5 \\* ULN\n  * Cirrhosis or current liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice\n* An abnormal Electrocardiogram (ECG) finding from the 12-lead ECG conducted at Screening, if considered clinically significant and likely to impact the participant's study participation, based on the evaluation of both the investigator and a pediatric cardiologist, or measured results of QT Corrected for Heart Rate using Fridericia's Formula (QTcF)\n\n  * \\>460 milliseconds (msec)\n  * \\>480 msec for participants with bundle branch block",{"count":365,"type":22},30,[25],"This study is aimed at assessing depemokimab as an add-on medicine for the treatment of asthma with type-2 inflammation in participants of 6 to 11 years of age. This study will test how the body processes depemokimab, how the drug works in the body, and its safety and tolerability.",[28],[61,348,370,371,372,373],"Asthma with Type 2 Inflammation","Pediatric Asthma","Eosinophilic Asthma","Eosinophilic phenotype","2026-06-22",{"date":230,"type":38},{"date":230,"type":22},{"date":378,"type":22},"2029-03-19",{"name":75,"class":45},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":278,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":101},"100638594","phase-2-dose-ranging-study-of-lq036-single-domain-antibody-nebulization-solution-in-poorly-controlled-asthma-100638594","NCT07589439","Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma","A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of LQ036 Single-Domain Antibody Nebulization Solution in Patients With Poorly Controlled Asthma","Inclusion Criteria:\n\n* Outpatients, aged 12 to 75 years inclusive, male or female, with body mass index (BMI) between 18 and 30 kg\u002Fm² inclusive. For participants aged 12 to 17 years, body weight must be ≥30 kg.\n* Diagnosed with bronchial asthma according to the 2025 Global Initiative for Asthma (GINA) guidelines prior to screening, with a documented history of asthma for ≥12 months.\n* For at least 3 months prior to screening, the participant has used inhaled corticosteroids (ICS) combined with at least one controller medication, and has maintained a stable treatment regimen and dosage for at least 1 month prior to screening. Low, medium, and high maintenance doses of ICS are defined according to the 2025 GINA guidelines (if multiple nebulized or combined administration methods are used, doses are to be combined).\n* At screening, pre-bronchodilator FEV₁ is ≥40% and \\\u003C80% of the predicted normal value. For participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and \\\u003C85% of the predicted normal value.\n* At screening, Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5.\n* At screening, a positive bronchodilator reversibility test (increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL, 15-30 minutes after inhalation of 400 μg salbutamol). If the reversibility test does not reach the positive threshold, one additional test is permitted within 7 days (excluding the day of the initial test). Alternatively, documented evidence of a positive bronchodilator reversibility test within 2 years prior to screening is acceptable.\n* At screening, blood eosinophil (EOS) count ≥150 cells\u002FμL or fractional exhaled nitric oxide (FeNO) ≥25 ppb.\n* Experienced ≥1 severe exacerbation within the 12 months prior to screening (not required for participants on low-dose ICS).\n* Participants fully understand the purpose, nature, methods, and possible adverse reactions of the study, voluntarily agree to participate, and sign the informed consent form before any study procedures begin.\n* At randomization, pre-bronchodilator FEV₁ has increased by ≤20% from the screening value, and remains ≥40% and \\\u003C80% of the predicted normal value (for participants on low-dose ICS, pre-bronchodilator FEV₁ is ≥40% and \\\u003C85% of the predicted normal value).\n* At randomization, ACQ-5 score ≥1.5.\n* During the run-in period, participant compliance with run-in medication and background medication is ≥80% and ≤120%, compliance with daily diary completion is ≥80%, and there are complete data for at least 4 days within the 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Life-threatening asthma, defined as an asthma episode requiring intubation within 1 year prior to screening or during the run-in period, and\u002For a history of hypercapnia, respiratory arrest, hypoxic seizures, asthma-related syncopal episodes, etc.\n* Experienced a severe asthma exacerbation within 1 month prior to screening.\n* History of allergy to biologics, or known hypersensitivity to any component of the investigational product.\n* Use of biologics (including but not limited to anti-IgE, anti-IL-5, anti-IL-5 receptor, anti-IL-4\u002F13 receptor, anti-TSLP monoclonal antibodies, etc.) and\u002For systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to screening.\n* Received intravenous immunoglobulin (IVIG) or allergen-specific immunotherapy (SIT) within 3 months prior to screening.\n* Received systemic corticosteroids (excluding topical, ophthalmic, or intranasal corticosteroids), antibiotics, antifungals, antivirals, antiparasitic drugs, non-selective beta-blockers, or herbal medicines with anti-asthmatic effects within 1 month prior to screening or during the run-in period.\n* Received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period.\n* Underwent bronchial thermoplasty within 12 months prior to screening.\n* Underwent major surgery within 8 weeks prior to screening, or plans to undergo surgery requiring general anesthesia or hospitalization for \\>1 day during the study period.\n* In the investigator's judgment, presence of respiratory diseases other than asthma, including but not limited to chronic obstructive pulmonary disease (COPD), asthma-COPD overlap syndrome (ACOS), or any other significant lung disease (e.g., active pneumonia, idiopathic pulmonary fibrosis, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, bronchiectasis, etc.), that may place the participant at undue risk or affect the evaluation of study results.\n* Based on imaging and investigator judgment, presence of active tuberculosis or non-tuberculous mycobacterial infection, untreated latent tuberculosis, or history of incompletely treated tuberculosis.\n* Active autoimmune disease or autoimmune disease requiring immunosuppressive therapy, such as rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.\n* Blood EOS \\>1500 cells\u002FμL at screening, or other systemic diseases that may cause elevated peripheral blood EOS count (e.g., hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis, etc.), which in the investigator's judgment may affect the evaluation of the drug.\n* Known or suspected immunodeficiency, including history of invasive opportunistic infection (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) even if resolved; or presence of unusually frequent, recurrent, or prolonged infections suggestive of an immunocompromised state.\n* Known parasitic infection, or suspected or high-risk parasitic infection in the investigator's judgment.\n* Active infection (e.g., upper respiratory tract infection) within 1 month prior to screening or during the run-in period, or acute infection requiring systemic anti-infective therapy.\n* History of lymphoproliferative disease or malignancy (participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ are eligible if they have completed curative treatment and have had no evidence of recurrence for at least 12 months prior to signing informed consent), or other medical history that in the investigator's judgment may affect the evaluation of the drug.\n* Presence of any other severe and\u002For uncontrolled disease or treatment that, in the investigator's judgment, may affect the evaluation of the drug, including but not limited to: severe neurological disease, severe mental disorder, uncontrolled diabetes mellitus, uncontrolled hypertension, major cardiovascular disease, corrected QT interval prolongation (male \\>450 ms, female \\>470 ms, Fridericia's formula), or persistent arrhythmia.\n* Current smoker or cessation of smoking for \\\u003C6 months; or former smoker with a smoking history of ≥10 pack-years (pack-years = \\[cigarettes per day \u002F 20\\] × years of smoking).\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening (participants with positive HBsAg but HBV-DNA below the lower limit of detection, or positive HCV antibody but HCV-RNA below the lower limit of detection, are eligible).\n* Participants with severe liver or kidney dysfunction, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN), or serum creatinine \\>1.5 × ULN.\n* Pregnant or breastfeeding women; women planning to become pregnant during the study or within 3 months after the end of the study; fertile women or men who, in the investigator's judgment, cannot use medically accepted reliable contraception from signing informed consent until 3 months after the last dose of study drug; positive pregnancy test result at screening or before randomization for fertile women.\n* Participation in another clinical study of a drug or device within 3 months prior to signing informed consent, with use of investigational drug\u002Fdevice; or still within the follow-up period of another clinical study or within 5 half-lives of the investigational drug (whichever is longer) at the time of signing informed consent.\n* History of blood donation or significant blood loss, blood transfusion, or use of blood products within 3 months prior to screening.\n* Known or suspected non-compliance, drug abuse, substance abuse, or alcohol abuse (daily pure alcohol intake \\>40 g for males, \\>20 g for females).\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.",{"count":388,"type":22},216,[282],"What is the goal of this study? The goal of this clinical trial is to find out whether the study drug LQ036 (a nebulized solution taken by inhaling through a nebulizer) works to improve lung function and asthma control in people whose asthma is not well controlled. The study will also learn about the safety of LQ036, how the body processes it, and whether the body develops an immune response to it.\n\nWhat are the main questions?\n\nThe most important question is:\n\n• Does LQ036 improve lung function (measured by FEV₁ - the amount of air you can blow out in one second) more than a placebo at Week 12?\n\nOther important questions include:\n\n* Does LQ036 improve lung function at other time points (weeks 1, 2, 4, 8, 16, 20, 24)?\n* Does LQ036 reduce asthma attacks (sudden worsening of asthma that needs extra treatment)?\n* Does LQ036 help people use less rescue medication (inhaler for quick relief) and have more days without asthma symptoms?\n* Does LQ036 improve scores on asthma control and quality of life questionnaires?\n* What medical problems do participants have when taking LQ036?",[28],{"date":203,"type":38},{"date":394,"type":38},"2025-09-30",{"date":396,"type":22},"2027-12",{"name":398,"class":45},"Shanghai Novamab Biopharmaceuticals Co., Ltd.",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":101},"100610474","phase-4-giving-asthmatics-intramuscular-steroids-for-preventing-return-to-the-emergency-department-100610474","NCT07228052","Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department","Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial","GASPING","Inclusion Criteria:\n\n* Adults ≥18 years old presenting to the ED with an asthma exacerbation\n* Diagnosed with asthma per International Classification of Diseases, 10th Revision (ICD-10) criteria or by the treating clinician\n* Discharged from the ED with a primary diagnosis of asthma exacerbation\n* Initiated systemic corticosteroids during the ED visit\n* Must be English or Spanish speaking\n\nExclusion Criteria:\n\n* Current use of systemic corticosteroids, including Emergency Medical Services (EMS) administration before ED arrival\n* History of severe adverse reactions to corticosteroids\n* Heart failure and uncontrolled diabetes (glucose \\>300mg\u002FdL in the ED)\n* Pregnancy or breastfeeding as prednisone is the preferred treatment for asthma in this population\n* Inability to provide informed consent",{"count":408,"type":22},182,[114],"This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.",[28],[413,414,415],"dexamethasone","prednisone","randomized controlled trial",{"date":262,"type":38},{"date":127,"type":22},{"date":419,"type":22},"2026-12",{"name":421,"class":100},"Montefiore Medical Center",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":245,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100611512","phase-2-study-of-inhaled-aro-rage-in-allergen-induced-mild-asthma-100611512","NCT07241546","Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma","A Randomized, Double-blind, Placebo-controlled Phase 2a Study of ARO-RAGE Inhalation Solution to Assess Efficacy on Small Airway Dysfunction in Allergen-induced Mild Asthma","Inclusion Criteria:\n\n* Clinically stable, mild atopic asthma (FEV1 ≥70% predicted)\n* Established allergy confirmed by positive skin prick test at screening\n* Willing and able to perform lung function tests and other study-related procedures\n* Participants of childbearing potential must consent to use a method of highly-effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last investigational product administration, whichever is later\n\nExclusion Criteria:\n\n* Concomitant diagnosis of a clinically important pulmonary disease other than asthma\n* Use of corticosteroids, immunosuppressives, or anti-inflammatory medications that interfere with inhaled challenges or inflammation, or chronic use of any other medication for treatment of allergic asthma\n* History or current medical condition contraindicating methacholine challenge\n\nNote: Additional inclusion\u002Fexclusion criteria may apply per protocol.",{"count":430,"type":22},36,[282],"The purpose of this study is to evaluate the impact of inhaled ARO-RAGE on the late asthmatic response (LAR) following an inhaled allergen challenge in participants with mild atopic asthma.",[28],{"date":327,"type":38},{"date":436,"type":38},"2026-03-30",{"date":438,"type":22},"2028-04",{"name":440,"class":45},"Arrowhead Pharmaceuticals",5,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":278,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":464},"100609791","phase-2-a-study-to-evaluate-brenipatide-compared-with-placebo-in-adult-participants-with-uncontrolled-moderate-to-severe-asthma-100609791","NCT07219173","A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma","A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma","Inclusion Criteria:\n\n* Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.\n* Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.\n* History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  * An established diagnosis of occupational asthma\n* Known pre-existing, clinically important lung condition other than asthma, including but not limited to:\n\n  * chronic respiratory infection\n  * bronchiectasis\n  * pulmonary fibrosis\n  * allergic bronchopulmonary aspergillosis\n  * emphysema\n  * chronic bronchitis\n  * eosinophilic granulomatosis with polyangiitis\n  * chronic obstructive pulmonary disease, and\n  * other mimics of asthma, that is, vocal cord dysfunction.\n* Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.",{"count":450,"type":22},531,[282],"The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.\n\nStudy participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.",[28],[455],"Incretin","2026-06-19",{"date":327,"type":38},{"date":459,"type":38},"2025-10-22",{"date":461,"type":22},"2028-06",{"name":463,"class":45},"Eli Lilly and Company",122,{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":245,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":101},"100549430","phase-1-a-study-to-compare-the-relative-potency-of-salbutamol-administered-via-metered-dose-inhalers-mdi-containing-propellants-hfa-152a-to-hfa-134a-in-mild-asthmatics-aged-18-to-65-inclusive-100549430","NCT06433921","A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive","A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects","Inclusion Criteria:\n\n1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.\n2. Participant must be 18 to 65 years of age inclusive, at the time of screening.\n3. ≥50 kg, at the time of screening.\n4. Body mass index (BMI) with 19.0-35.0 kg\u002Fm2 inclusive, at the time of screening.\n\n4\\. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg\u002Fday fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.\n\niii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg\u002Fday fluticasone propionate or equivalent as defined by GINA \\[GINA, 2023\\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.\n\n6\\. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.\n\n7\\. Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg\u002FmL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods).\n\n10\\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.\n\n11\\. Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n\n12\\. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.\n   2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.\n   3. Asymptomatic gallstones.\n   4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.\n   5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.\n   6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.\n2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.\n3. Participants who are currently or in the last 15 days have worked nightshifts.\n4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \\>21 units for males or \\>14 units for females.\n5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.\n6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to \"vape\" within 12 months prior to the start of the study.",{"count":473,"type":22},84,[249],"The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \\[PC20\\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.",[28,477],"Mild Asthma",[479,480,481,482,483],"Salbutamol","Propellant HFA-152a","Propellant HFA-134a","Metered dose inhalers","Mild asthma",{"date":262,"type":38},{"date":486,"type":38},"2024-08-14",{"date":488,"type":22},"2027-02-26",{"name":75,"class":45},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":512},"100572351","remote-anxiety-management-for-ics-resistant-asthma-study-100572351","NCT06732141","Remote Anxiety Management for ICS-resistant Asthma Study","Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled Trial","RAMICS","Inclusion Criteria:\n\n1. Age Requirement:\n\n   Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to interventions.\n2. Diagnosed Asthma:\n\n   1. Diagnosis must meet the criteria of the Global Initiative for Asthma (GINA) or the American Academy of Asthma guidelines, with at least one confirmed diagnosis by a specialist in the past six months.\n   2. Asthma severity must range from mild to moderate persistent, in the chronic management phase, excluding patients in acute exacerbation phases for clearer evaluation of adherence and intervention effects.\n3. ICS Treatment History:\n\n   1. Participants must have been on inhaled corticosteroid (ICS) therapy for at least six months, ensuring sufficient treatment history for adherence and effect evaluation.\n   2. No major changes to asthma control medication regimen in the past six months, ensuring adherence and intervention outcomes are not confounded by treatment changes.\n4. Poor Medication Adherence:\n\n   Identified using the Medication Adherence Report Scale (MARS-10), with an average score \\\u003C4.5, indicating suboptimal adherence.\n5. Presence of Anxiety Symptoms:\n\n   1. Confirmed through the Hamilton Anxiety Rating Scale (HAMA), with a score ≥14, indicating clinically significant anxiety.\n   2. Anxiety symptoms must be related to asthma treatment, particularly concerns about ICS side effects or long-term use, ensuring the psychological intervention targets relevant issues.\n6. Ability to Communicate by Phone:\n\n   Participants must have stable access to a phone and be willing to engage in telephone-based psychological interventions.\n7. Stable Health Condition:\n\nAsthma status must be stable, with no acute exacerbations or significant changes in the past month.\n\nExclusion Criteria:\n\n1. Severe Psychiatric or Cognitive Disorders:\n\n   1. Diagnosis of major psychiatric disorders, such as major depressive disorder, bipolar disorder, schizophrenia, or other severe mental illnesses within the past six months, based on DSM-5 criteria.\n   2. Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or adherence to the intervention.\n   3. Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.\n2. Substance Abuse or Dependence:\n\n   History of alcohol or drug abuse within the past six months, including but not limited to opioids, benzodiazepines, or illicit substances.\n3. Severe Comorbidities:\n\n   1. Uncontrolled respiratory or cardiovascular conditions, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, heart failure, or uncontrolled hypertension, that could significantly impact asthma control and overall health.\n   2. Chronic diseases requiring long-term systemic corticosteroid therapy, such as rheumatic or autoimmune diseases, that may interfere with ICS treatment and study outcomes.\n4. Pregnancy or Lactation:\n\n   Pregnant or breastfeeding women are excluded due to the unclear risks of ICS treatment and anxiety management interventions in these populations.\n5. Allergic Bronchopulmonary Aspergillosis (ABPA) or Related Conditions:\n\n   Diagnosed ABPA or other respiratory diseases with mechanisms distinct from asthma, which could confound the assessment of ICS treatment effects.\n6. Participation in Other Interventional Clinical Trials:\n\n   Participation in another interventional clinical trial within the past three months, particularly those involving respiratory diseases or medication adherence management, to avoid confounding effects on outcomes.\n7. Incompatibility with Telephone-Based Interventions:\n\n   Inability to reliably receive or engage in telephone-based psychological interventions due to hearing impairments, communication barriers, or other reasons.\n8. Adverse Reactions to Psychological Interventions:\n\n   Documented refusal of or adverse reactions to psychological interventions, such as phone-based relaxation or motivational interviewing, that could affect the feasibility and effectiveness of the study.\n9. History of Major Surgery or Hospitalization:\n\nHistory of major surgery or hospitalization (unrelated to asthma) within the past six months that might impact current health status and introduce bias into the study outcomes.","80 Years",{"count":388,"type":22},[87],"This study, the Remote Anxiety Management for ICS-resistant Asthma Study (RAMICS), explores strategies to improve medication adherence and anxiety management in asthma patients who are resistant to using inhaled corticosteroids (ICS) due to anxiety. Asthma is a chronic respiratory disease affecting millions worldwide, and ICS therapy is essential for controlling symptoms and preventing severe exacerbations. However, many patients struggle with adherence, especially those with anxiety about ICS side effects. RAMICS is a multicenter, open-label, randomized controlled trial designed to evaluate the effectiveness of personalized telephone-based interventions, including medication education, progressive muscle relaxation (PMR), motivational interviewing (MI), and lung rehabilitation guidance. The study will enroll 216 adult asthma patients with poor ICS adherence and clinically significant anxiety. Participants will be randomized into two groups: the intervention group, receiving weekly telephone sessions, and the control group, receiving standard follow-up calls. The study aims to assess improvements in ICS adherence, reductions in anxiety and depression, better asthma symptom control, and enhanced quality of life. Outcomes will be evaluated immediately after the 8-week intervention and during a 3-month follow-up. By addressing both psychological and medication adherence challenges, this research aims to provide practical solutions for improving asthma management.",[28],{"date":504,"type":38},"2026-06-18",{"date":506,"type":38},"2024-12-13",{"date":508,"type":22},"2027-06-30",{"name":510,"class":511},"First Affiliated Hospital of Ningbo University","NETWORK",11,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":110,"sex":17,"minAge":54,"maxAge":278,"enrollmentInfo":520,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"100548316","a-translational-study-to-describe-clinical-characteristics-biomarkers-and-to-identify-phenotypes-and-endotypes-associated-with-differential-outcomes-in-chinese-population-100548316","NCT06419413","A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population","A Transnational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population","Inclusion Criteria:\n\n* Age 18 to 75 years of age\n* acceptable FEV1 (according to ATS and ERS)\n* compliance with study procedures All Asthma Cohorts\n* physician diagnosed Asthma greater or equal to 3 months prior to screening visit\n\nExclusion Criteria:\n\n* history of alcohol or drug abuse within the past year\n* pregnant at time of an assessment\n* has an altered mental status at the time of informed consent\n* receipt marketed or investigational biologic(s) within 3 months or 5 half-lives prior to visit 1, whichever is longer\n* history or current upper or lower respiratory infection or symptoms within 2 weeks of baseline assessments\n* terminal diseases and\u002For organ failure or participants otherwise considered not appropriate for the study participation\n* Receipt LTRAs or 5-lipoxygenase (5-LO) inhibitors (eg zileuton and montelukast) within 1 month or 5 half-lives prior to baseline, whichever is longer.",{"count":521,"type":22},355,"A Translational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes associated with Differential Outcomes that may Support Future Development of Personalised Treatment Strategies in Chinese Population",[28],{"date":504,"type":38},{"date":526,"type":38},"2024-01-08",{"date":528,"type":22},"2026-10-08",{"name":236,"class":45},21,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":101},"100234291","nhales-natural-history-of-asthma-with-longitudinal-environmental-sampling-100234291","NCT02327897","NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)","Natural History of Asthma With Longitudinal Environmental Sampling","* Inclusion Criteria\n\nParticipants must meet all of the following criteria for enrollment:\n\n* Male or female, 18 to 60 years of age\n* Must have clinical evidence of moderate-severe atopic asthma:\n\n  * self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms)\n\nwithin the past year, and\n\n--\\*a positive methacholine test confirming diagnosis \\[provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) \\\u003C16 mg\u002FmL for participants on inhaled corticosteroids and \\\u003C8 mg\u002FmL for participants not on inhaled corticosteroids\\] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and\n\n--no other diagnosis that could explain symptoms.\n\nIf there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge.\n\n* Permanently resides within 50 miles of the CRU.\n* Able to present a valid government issued form of identification for entry to the NIEHS campus\n* Able to receive asthma treatment medication(s) via mail\n* Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol\n* Access to a vacuum cleaner with a detachable hose component\n\n  * If a woman is found to be pregnant or breastfeeding at the screening or baseline visit, they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy procedures in this study while pregnant.\n\nBronchoscopy Visit Inclusion Criterion\n\nIn addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy visit.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:\n\n* Current smoker, significant second-hand smoke exposure (defined by urine cotinine \\>200 ng\u002FmL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes.\n* piCO Smokealyzer value of \\>11ppm\n* History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension\n* Allergy or history of adverse reactions to methacholine\n* Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures\n* Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment\n\nBronchoscopy Visit Exclusion Criteria\n\nIn addition to the above exclusion criteria, participants meeting any of the following criteria will not be eligible for enrollment into the bronchoscopy visit:\n\n* Pregnancy, as indicated by urine pregnancy test, if of childbearing age and\u002For ability contraindication\n* Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy\n* Bleeding disorders\n* Facial deformity, major facial surgery\n* Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit\n* Severe persistent asthma, defined as by ATS-ERS criteria.\n* Allergy or history of adverse reactions to lidocaine\n* Temperature \\>37.6 (Infinite)C; blood pressure \\\u003C90\u002F50 mm Hg or \\>160\u002F100 mm Hg; pulse rate \\\u003C50 or \\>100 beats\u002Fminute\n* Body weight \\\u003C50 kg (\\\u003C110 lbs)\n* The following abnormal lab values (values obtained during clinical assessment):\n\n  * Platelet count \\\u003C100,000 per microliters\n  * White blood cells count \\\u003C3000 per microliters\n  * Absolute neutrophil count \\\u003C1000 per microliters\n  * Hematocrit \\\u003C35% for both female and male\n  * Prothrombin time (PT) \u002F abnormal international normalized ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges\n  * Serum creatinine \\>1.4 mg\u002FdL\n\nIf a participant is recruited for the Bronchoscopy Visit but does not have current lab values (within 4 weeks), the participant may be asked to return to the CRU for an additional blood draw in order to run the requisite clinical assessments for safety purposes. The participant will be compensated for the additional visit. This is anticipated to be a rare occurrence, as the study team will make all efforts to schedule and complete the bronchoscopy procedure while the lab results are current.\n\nParticipants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.","60 Years",{"count":540,"type":22},400,"Background:\n\n\\- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma.\n\nEligibility:\n\n\\- Nonsmoking adults age 18 - 60 who have moderate to severe asthma.\n\nDesign:\n\n* Participants will complete a medical history form before the first visit.\n* Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples.\n* Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys.\n* Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant.\n* Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.",[28],[544,545,546,176],"Atopic Asthma","Exposures","Disease Progression",{"date":504,"type":38},{"date":549,"type":38},"2015-09-10",{"date":551,"type":22},"2030-04-01",{"name":182,"class":156},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":101},"100641729","execise-intervention-in-adult-severe-asthma-100641729","NCT07655037","Execise Intervention in Adult Severe Asthma","Exercise Intervention in Severe Asthma: a Randomized Controlled Trial in Adults on Biological Treatment for Asthma","Inclusion Criteria:\n\n* Age over 18 years\n* Physician-diagnosed severe asthma defined with the GINA criteria and with a decision to initiate biological treatment (omalizumab, mepolizumab, benralizumab, dupilumab or tezepelumab) for severe asthma\n\nExclusion Criteria:\n\n* Upcoming major surgery\n* Acute musculoskeletal disease which unables regular exercise\n* Inability to commit to the appointments and the exercise plan due to exhaustion or fatigue\n* Pregnancy",{"count":561,"type":22},60,[87],"Physical activity has been shown to improve asthma control in individuals with asthma. Patients with severe asthma frequently experience exacerbations, which often result in a physically inactive lifestyle. The investigators therefore hypothesize that patients with severe asthma who initiate biological therapy may particularly benefit from increased physical activity, both in terms of exercise capacity and asthma control.\n\nThe aim of this study is to determine whether an individually tailored exercise program improves exercise capacity and asthma control in patients with severe asthma. Additionally, the study evaluates the effects of the intervention on asthma symptoms, frequency of exacerbations, lung function, quality of life, and body composition.\n\nThe primary outcome is the change in exercise tolerance, measured as peak oxygen uptake during cardiopulmonary exercise testing.\n\nSecondary outcomes include asthma symptoms (proportion of patients reporting improvement based on the Asthma Control Test), frequency of exacerbations, changes in lung function (FVC and FEV1), asthma-related quality of life (AQLQ), and changes in body composition (body mass index and waist circumference).\n\nAt baseline, all participants undergo fitness assessments, including cardiopulmonary exercise testing and muscle strength tests. Participants are then randomized into two groups. The intervention group receives an individually tailored 6-month exercise program designed by a sports medicine physician and a physiotherapist based on baseline fitness level. The control group receives standard advice to increase physical activity. Asthma medication is managed according to standard clinical practice in both groups.\n\nFitness assessments are repeated at 6 months for all participants, and asthma control is evaluated at 6 and 12 months",[565,28],"Severe Asthma",[567,568],"severe asthma","biological treatment","2026-06-15",{"date":265,"type":38},{"date":572,"type":38},"2026-03-18",{"date":574,"type":22},"2028-10",{"name":576,"class":100},"Helsinki University Central Hospital",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":278,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":596},"100579860","phase-3-tqc2731-clinical-trial-for-the-treatment-of-severe-asthma-with-injection-100579860","NCT06829784","TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection","A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injections in Patients With Poorly Controlled Severe Asthma","Inclusion Criteria:\n\n* Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial;\n* Age 18 \\~ 75 years old, gender is not limited;\n* Documented physician diagnosis of asthma at least 12 months prior to Visit 1;\n* Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1;\n* There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1;\n* There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment.\n* Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed.\n\nExclusion Criteria:\n\n* Have a clinically significant lung disease other than asthma；\n* Pre-existing autoimmune disease;\n* A history of known or suspected immunosuppression, including a history of invasive opportunistic infections;\n* Any disease that has not been determined to be stable by the investigator；\n* Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study.\n* Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \\\u003C10 pack-years had quit smoking less than 6 months before interview 1);\n* Other factors determined by the investigator that subjects were not suitable to participate in the study.",{"count":585,"type":22},660,[25],"This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.",[28],{"date":265,"type":38},{"date":591,"type":38},"2025-03-21",{"date":593,"type":22},"2028-03",{"name":595,"class":45},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.",101,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":101},"100466247","thermotherapy-against-persistent-bacterial-lung-infections-100466247","NCT05351242","THERMotherapy Against Persistent Bacterial LUNG Infections","Thermotherapy Against Persistent Bacterial LUNG Infections","THERMA-LUNG","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Competent and capable\n* FEV1\\>1,0 L\n* Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics\n* Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months\n\nExclusion Criteria:\n\n* Allergy to lidocaine and\u002For midazolam\n* Contraindications to bronchoscopy\n* Previous severe laryngospasm (intubation requiring)\n* Pregnancy\u002Fbreastfeeding\n* Severe linguistic problems or inability to give informed consent\n* Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others",{"count":56,"type":22},[87],"The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.",[609,610,28,611,612,613],"Lung Diseases, Obstructive","Bronchiectasis","Copd","Chronic Obstructive Pulmonary Disease","Chronic Lung Infections",{"date":265,"type":38},{"date":616,"type":22},"2026-10-01",{"date":618,"type":22},"2029-12-31",{"name":620,"class":100},"Chronic Obstructive Pulmonary Disease Trial Network, Denmark"]