[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-asthma":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,45,74,97,123,146,169,191,209,236,270,292,318,343,369,396,423,445,467,493,518,543,570,599,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591807","evaluation-of-ventilation-defects-downstream-of-mucus-plugs-in-patients-with-muco-obstructive-lung-disease-100591807",false,"NCT06985225","Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease","Inclusion Criteria:\n\n* Adequate completion of informed consent process with written documentation\n* Patients 18 - 65 years old\n* • Physician diagnosis of muco-obstructive pulmonary disease, including cystic fibrosis, severe asthma, chronic obstructive pulmonary disease, or non-cystic fibrosis bronchiectasis for \\> 1 year\n* Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.\n\nExclusion Criteria:\n\n* Respiratory tract infection within the 4 weeks prior to Visit 1\n* Body mass index (BMI) \\> 30 at Visit 1\n* One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1\n* ER visit related to pulmonary condition within the previous 4 weeks of Visit 1\n* Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)\n* Resting O2 saturation \\\u003C90% with maximum supplemental O2 delivered by nasal canula\n* Positive urine pregnancy test\n* Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study\n* Unable or unlikely to complete study assessments in the opinion of the Investigator\n* Study intervention poses undue risk to patient in the opinion of the Investigator\n* Conditions that will prohibit MRI scanning determined by the MRI safety screening.","ALL","18 Years","65 Years",{"count":20,"type":21},8,"ESTIMATED","OBSERVATIONAL","In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.",[25,26,27,28],"Severe Asthma","COPD","Non-CF Bronchiectasis","Cystic Fibrosis (CF)",[30,31,25,26,27],"Xenon MRI","Mucus Plug","RECRUITING","2026-06-26",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2025-06-01",{"date":40,"type":21},"2026-12",{"name":42,"class":43},"University of Kansas Medical Center","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100620901","phase-3-phase-3b-study-in-patients-with-severe-asthma-treated-with-tezepelumab-100620901","NCT07363642","Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab","TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab","TAPER","Inclusion Criteria:\n\n1．Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent\u002Fconsent requirements for children and parent\\[s\\]\u002Fguardian\\[s\\]) and according to international guidelines and\u002For applicable local guidelines.\n\nAge 2. Patient must be aged 12-80 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study.\n\nType of Patient and Disease Characteristics 3. Documented history of physician-diagnosed asthma prior to Visit 1\n\n* Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1, or FEV1≥400 mL variability over time, or positive result of branchial provocation test within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 1.\n\n  4\\. Documented current maintenance treatment with MD\u002FHD ICS + LABA with up to one additional controller\n* Other acceptable asthma controller includes LTRA, LAMA or theophylline 5. On stable MD\u002FHD ICS (\\>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA stable for ≥2 months prior to enrollment 6. On stable LTRA or LAMA or theophylline (≥2 weeks) is allowed 7. Documented ACQ-5 ≥ 1.5 in Visit 1 8. Documented at least one exacerbation in the year prior to enrolment\n* A qualifying historical asthma exacerbation is a symptomatic worsening requiring systemic corticosteroid (i.e., oral, intravenous (IV) or intramuscular; any healthcare setting or temporary increase from a stable maintenance dose of oral corticosteroid) or that resulted in hospitalization or emergency room\u002Furgent care visit.\n* Source documentation is required for physician-diagnosed asthma, ICS-LABA use and asthma exacerbations over the prior year. A patient verbal history suggestive of asthma symptoms and\u002For prior asthma exacerbations, but without supporting documentation, is not sufficient to satisfy these inclusion criteria.\n* Examples of acceptable documentation of the asthma disease state and prior asthma exacerbations include clinic visit (primary or specialist Health care provider (HCP)), emergency room\u002Furgent care, or hospital records listing asthma as a current problem, plus documentation of at least 1 asthma exacerbations during the 12 months prior to ICF.\n\nWeight 9. Weight of ≥40 kg at Visit 1. Sex and Contraceptive\u002FBarrier Requirements 10. Male and\u002For female Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nFemale patients:\n\n* Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to Visit 1(Week -1 to Week 0) without an alternative medical cause. The following age-specific requirements apply:\n* Females \\\u003C 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.\n* Females ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.\n* Female patients of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 8 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician.\n* The following are not acceptable methods of contraception: periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea. Female condom and male condom should not be used together.\n* All WOCBP must have a negative serum pregnancy test result at Visit 1(Week -1 to Week 0).\n* Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the patient (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \\[(periodic abstinence eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\\], a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device\u002Flevonorgestrel intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Unable to commit to the scheduled visits as required by the protocol, or unable to commit to undergoing protocol guided reductions in asthma therapy, as directed by the Investigator.\n2. Clinically important pulmonary disease other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease \\[COPD\\], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that is associated with elevated peripheral eosinophil counts (e.g., allergic bronchopulmonary aspergillosis\u002Fmycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).\n\n   • Within the 12 months prior to Visit 1, a CT scan is required to exclude related diseases.\n3. Current smokers at Visit 1 are not allowed. Former smokers with smoking history ≥ 10 pack-years at Visit 1 are not allowed; Former smokers with a smoking history of \\\u003C10 pack years must have stopped for at least 6 months to be eligible.\n4. History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0).\n5. A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1(Week -1 to Week 0) that has not been treated with, or has failed to respond to, standard of care therapy.\n6. History of anaphylaxis to any biologic therapy.\n7. Known history of allergy or reaction to any component of the study treatment formulation.\n8. Respiratory exacerbation requiring use of Systemic corticosteroids (SCS) or acute upper\u002Flower respiratory infection that required antibiotics or antiviral medication within 30 days prior to Visit 1(Week -1 to Week 0). An extension of the screening period up to 3 months is allowed to ensure that a patient recovering from any repiratory exacerbation or acute upper\u002Flower respiratory infection can be included.\n9. A history of known immunodeficiency disorder, including human immunodeficiency virus.\n10. Current or history of malignancy within 5 years before the screening visit with the following exceptions:\n\n    * In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to screening.\n    * Basal cell or superficial squamous skin cancer.\n    * Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.\n11. Exclusion for any of the following:\n\n    * Previous allogeneic bone marrow transplant.\n    * Non-leucocyte depleted whole blood transfusion within 120 days of genetic sample collection.\n12. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:\n\n    1. Affect the safety of the patient throughout the study,\n    2. Confound the study results or impact the scientific validity of the data outcome,\n    3. Impede the patient's ability to complete the entire duration of study. Prior\u002FConcomitant Therapy\n13. Oral corticosteroid use during 4 weeks prior to Visit 1(Week -1 to Week 0).\n14. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months or 5 halflives (whichever is longer) prior to the date informed consent is obtained.\n15. Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives (whichever is longer) prior to Visit 1(Week -1 to Week 0) or receipt of any investigational non biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1(Week -1 to Week 0). Exception:\n\n    1. For marketed non-respiratory biologics, it is allowed if the patient is stable on treatment for at least 3 months prior to Visit 1(Week -1 to Week 0) and throughout the study.\n    2. Covid-related prevention and treatment\n16. Receipt of live attenuated vaccines 30 days prior to the date of first dose of Tezepelumab.\n17. Intention to use any concomitant medication that is not permitted or failure to complete the required washout period for a particular prohibited medication.\n18. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.\n19. Received bronchial thermoplasty (BT) as treatment of asthma within 12 months prior to Visit 1.\n20. Received treatment with traditional Chinese herbs or proprietary Chinese medicines that have anti-asthmatic effects (excluding topical Chinese herbs) within 4 weeks prior to Visit 1 (Week -1 to Week 0) Prior\u002FConcurrent Clinical Study Experience\n21. Concurrent participation in another clinical study with an Investigational Product or a post-authorization safety study\n\n    Diagnostic Assessments\n22. Any clinically significant abnormal findings in physical examination, medical history, vital signs, haematology, or clinical chemistry during the enrolment period, which in the opinion of the investigator, may put the patient at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the patient's ability to complete the entire duration of the study, e.g. HBV, HCV, active liver disease, Receipt of live attenuated vaccines 30 days prior to the date of visit 1.\n\n    Other Exclusions\n23. For females only - currently pregnant (confirmed with positive pregnancy test), breast-feeding, or lactating.\n24. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n25. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n26. Previous enrolment in the present study.","12 Years","80 Years",{"count":56,"type":21},400,"INTERVENTIONAL",[59],"PHASE3","This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.",[25],[25],"2026-06-24",{"date":65,"type":36},"2026-06-25",{"date":67,"type":36},"2026-01-28",{"date":69,"type":21},"2029-03-31",{"name":71,"class":72},"AstraZeneca","INDUSTRY",76,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100552378","clinical-and-demographic-features-of-patients-with-uncontrolled-severe-asthma-in-russia-corsar-100552378","NCT06472310","Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)","An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation","CORSAR","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of inclusion;\n2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;\n3. Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \\> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and\u002For ALP, and\u002For LAMA, and\u002For systemic corticosteroids (sCS), and\u002For immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion.\n\n   Uncontrolled asthma is defined as ACQ-5\\>1.5.\n4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.\n\nExclusion Criteria:\n\n1. Patients receiving any biological therapy currently or within 52 weeks prior to inclusion;\n2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;\n3. The participation in any clinical study currently or within 52 weeks prior to inclusion;\n4. An acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results.",{"count":83,"type":21},5000,"This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.",[25],[87,88],"uncontrolled severe asthma","SA","2026-06-23",{"date":63,"type":36},{"date":92,"type":36},"2024-06-06",{"date":94,"type":21},"2027-06-30",{"name":71,"class":72},37,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":57,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":44},"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":105,"type":21},60,[107],"NA","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",[25,110],"Asthma",[112,113],"severe asthma","biological treatment","2026-06-15",{"date":116,"type":36},"2026-06-17",{"date":118,"type":36},"2026-03-18",{"date":120,"type":21},"2028-10",{"name":122,"class":43},"Helsinki University Central Hospital",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":57,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":44},"100641542","phase-4-fasenra-an-asthma-study-100641542","NCT07654842","Fasenra: An Asthma Study","Fasenra Demonstrates Durability Over the Full 8-week Treatment Period","Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.\n2. At least 18 years of age at the time of signing the informed consent at Visit 1.\n3. Documented asthma diagnosis ≥12 months prior to Visit 1. This may be documented by physician-diagnosis or by documented pharmacy records.\n4. Treated with a daily ICS-containing maintenance inhaler for asthma at a stable dose for ≥3 months prior to Visit 1. This inhaler may contain ICS alone, or in combination with a LABA or LABA-LAMA. The prescribed inhaler must be compatible with a study-provided EMM (see Appendix A).\n5. Prescribed a SABA-containing reliever inhaler, AND willing to use study-provided ICS-SABA reliever with EMM provided by the study.\n6. Prescribed benralizumab for severe eosinophilic asthma for ≥6 months AND has had ≥4 benralizumab doses (3 loading doses + at least 1 8-week dosing interval).\n\nExclusion Criteria:\n\n1. Current smoker (including tobacco, vaping, and marijuana). Former smokers must have stopped ≥6 months prior to Visit 1.\n2. Has a known, preexisting, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, or any other system abnormalities that are uncontrolled with standard treatment, which, in the investigator's opinion, would compromise the participant's safety, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence.\n3. History of use of any biologic therapy for asthma (other than benralizumab) within 5 half-lives or 5 months, whichever is longer, before Visit 1.\n4. A severe asthma exacerbation within 4 weeks of Visit 1. For this study, a severe asthma exacerbation is defined as an episode of worsening asthma symptoms that result in at least one of the following:\n\n   * Use of systemic corticosteroids for at least 3 consecutive days (or a single depo-injectable dose of corticosteroids)\n   * An inpatient hospitalization (defined as admission to an inpatient facility and\u002For evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma\n   * An emergency department visit (defined as evaluation and treatment for \\\u003C24 hours in an emergency department or urgent care) due to asthma that required systemic corticosteroids (as per above)\n5. Current enrollment in an asthma-related clinical trial.\n6. Any known history of adverse reactions to budesonide-albuterol.",{"count":131,"type":21},40,[133],"PHASE4","The goal of this observational study is to learn more about the effectiveness of benralizumab (Fasenra, 30 mg every 8 weeks) in maintaining asthma control in people with severe eosinophilic asthma.\n\nParticipants will have electronic medication monitors fitted to their usual maintenance inhaler, as well as a study-provided anti-inflammatory rescue inhaler, albuterol-budesonide (AirSupra). These monitors will track when each inhaler is used. Participants will also upload time-stamped photos of their benralizumab administration to their electronic medical records.",[136,25,137,110],"Eosinophilic Asthma","Severe Eosinophilic Asthma","NOT_YET_RECRUITING","2026-06-12",{"date":116,"type":36},{"date":35,"type":21},{"date":143,"type":21},"2028-01-01",{"name":145,"class":43},"Endeavor Health",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":153,"targetDuration":4,"studyType":57,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100614217","phase-3-a-study-to-investigate-gb-0895-adjunctive-therapy-in-adults-and-adolescents-with-severe-uncontrolled-asthma-solairia-1-100614217","NCT07276724","A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma","1. Adults and adolescents ≥ 12 and ≤ 80 years of age.\n2. Documented physician diagnosis of asthma for ≥ 2 years.\n3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.\n4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.\n5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\\u003C80% predicted at Screening Visit 1.\n6. Adolescents 12 to \\\u003C 18 years of age at Screening Visit 1: A pre-BD FEV1 \\\u003C 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\\u003C 0.80.\n7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.\n8. ACQ-6 score ≥ 1.5 at the Screening Visit.\n9. Weight ≥40 kg at the Screening Visit 1\n\nExclusion Criteria:\n\n1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.\n2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and\u002For chronic bronchitis), or a history of lung cancer.\n3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).\n4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.\n5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.\n6. A current malignancy or previous history of cancer within 5 years before screening.\n7. Clinically significant infection that is not resolved before study enrollment.\n8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.\n9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.\n10. Former smokers with a smoking history of \\\u003C10 pack-years and users of vaping\u002Fe-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.\n11. Hepatitis B, C, or HIV.\n12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \\>1 day during the study.\n13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months before Screening Visit 1 or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.\n14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.\n15. Treatment with systemic immunosuppressive\u002Fimmunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.\n16. Receipt of an investigational biologic within 4 months or 5 half-lives, OR receipt of an investigational non-biologic within 30 days or 5 half-lives before Screening Visit 1.\n17. Known history of sensitivity to any component of the study treatment formulation.\n18. History of life-threatening anaphylaxis following any biologic therapy.\n19. Concurrent enrollment in another clinical study involving investigational product (IP).\n20. Subject has been randomized in the current study or previous GB-0895 studies.\n21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion.\n22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.\n23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.\n24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.\n25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.\n26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.\n27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.\n28. Women who are pregnant, lactating, or planning to become pregnant during the study.\n29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.",{"count":154,"type":21},786,[59],"The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.\n\nThe study details include:\n\nStudy treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.\n\nVisit frequency: every 1-2 months after the first month.",[25],[110,25],"2026-06-09",{"date":161,"type":36},"2026-06-11",{"date":163,"type":36},"2025-12-03",{"date":165,"type":21},"2028-12",{"name":167,"class":72},"Generate Biomedicines",35,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100592796","tezepelumab-tezspire-regulatory-postmarketing-surveillance-in-korea-100592796","NCT06998095","Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea","Tezepelumab","Inclusion Criteria:\n\n1. Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information\n2. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study\n\nExclusion Criteria:\n\n1. Other off-label indications according to the locally approved prescribing information\n2. Current participation in any interventional trial",{"count":177,"type":21},210,"The objectives of this study are to describe the incidence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma or CRSwNP in South Korea.",[25,180],"Chronic Rhinosinusitis With Nasal Polyps(CRSwNP)",[112,182],"Chronic Rhinosinusitis with Nasal Polyps(CRSwNP)","2026-06-03",{"date":185,"type":36},"2026-06-04",{"date":187,"type":21},"2026-11-28",{"date":189,"type":21},"2029-10-31",{"name":71,"class":72},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":196,"targetDuration":4,"studyType":57,"phases":197,"briefSummary":156,"conditions":198,"keywords":199,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100620609","phase-3-a-study-to-investigate-gb-0895-adjunctive-therapy-in-adults-and-adolescents-with-severe-uncontrolled-asthma-solairia-2-100620609","NCT07359846","A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)",{"count":154,"type":21},[59],[25],[110,25],"2026-05-14",{"date":202,"type":36},"2026-05-18",{"date":204,"type":36},"2026-01-20",{"date":206,"type":21},"2029-01",{"name":167,"class":72},14,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":57,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100570324","phase-4-tezepelumab-in-the-treatment-of-emergency-room-asthma-in-adults-teraa-100570324","NCT06705764","Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)","Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension","TERAA","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Female and\u002For male aged 18 to 55 years\n3. History of physician-diagnosed asthma\n4. All subjects will have been prescribed high dose inhaled corticosteroid (\\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment.\n5. Documented history of at least one moderate or severe asthma exacerbation in the past 12 months\n6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.\n7. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of study drug\u002Fmatching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.\n8. Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.\n9. Subject willing and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site)\n2. Previous enrolment in the present study\n3. Participation in another clinical study with an investigational product during the last 6 months\n4. Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.\n5. Patients who are admitted to hospital at screening.\n6. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.\n7. Known to have tested positive for human immunodeficiency virus\n8. Current smokers with a smoking history of \\> 10 pack-years. Current smokers with a smoking history of \\\u003C 10 pack-years are permitted . Ex-smokers should not have a smoking history \\> 10 pack-years at screening. Participants who use e-cigarettes will also be excluded from the study.\n9. Known history of drug or alcohol abuse within 1 year of screening\n10. Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).\n11. History of QT prolongation associated with other medications that required discontinuation of that medication.\n12. Congenital long QT syndrome.\n13. Creatinine clearance \\\u003C50 ml\u002Fmin (calculated by Cockcroft-Gault formula, reference Appendix G).\n14. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n15. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.","55 Years",{"count":219,"type":21},100,[133],"Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.\n\nA new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.",[25],[110,25,224,174,225],"Asthma Exacerbation","Emergency deparment visits for asthma","2026-05-05",{"date":228,"type":36},"2026-05-06",{"date":230,"type":21},"2026-05-11",{"date":232,"type":21},"2026-11",{"name":234,"class":43},"University of Alberta",2,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":57,"phases":245,"briefSummary":246,"conditions":247,"keywords":256,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":44},"100388150","deployment-o-the-multidisciplinary-prospective-cohort-imminent-100388150","NCT04334031","Deployment o the Multidisciplinary Prospective Cohort Imminent","IMMINeNT","Inclusion Criteria:\n\n* Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology)\n* Social insured\n* Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures.\n\nExclusion Criteria:\n\n* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system.\n* Pregnant or breastfeeding woman\n* Persons deprived of liberty\n* Protected minors or adults\n* Persons who have refused or are incapable of giving informed consent\n* Persons in Emergency Situations",{"count":244,"type":21},2200,[107],"Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions.\n\nBeyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as \"targeted therapies\". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment.\n\nThese similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.",[248,249,25,250,251,252,253,254,255],"Chronic Inflammatory Disease","Angioedema","Lupus","Atopic Dermatitis","Psoriatic Arthritis","Multiple Sclerosis","Systemic Sclerosis","Behçet Disease",[257,258,259,260,261],"Immune Mediated Inflammatory Diseases (IMIDs)","biomarker","cohort study","quality of life","disease severity","2026-04-28",{"date":226,"type":36},{"date":265,"type":36},"2020-07-20",{"date":267,"type":21},"2031-07-21",{"name":269,"class":43},"University Hospital, Lille",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":279,"studyType":22,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100366001","international-severe-asthma-registry-canadian-cohort-100366001","NCT04045587","International Severe Asthma Registry: Canadian Cohort","ISAR","Inclusion Criteria:\n\n* Participants 18 years or older\n* Participants receiving treatment according to GINA Step 5 or uncontrolled in GINA Step 4 (uncontrolled is defined as having severe asthma symptoms or frequent exacerbations)\n\nExclusion Criteria:\n\n-Participants with mild to moderate asthma",{"count":278,"type":21},714,"5 Years","The International Severe Asthma Registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. The study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. The purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. Medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. The Canadian cohort of the registry will collect information from Canadian participants with severe asthma across seven different sites.",[25],"2026-04-27",{"date":284,"type":36},"2026-05-01",{"date":286,"type":36},"2018-11-06",{"date":288,"type":21},"2028-12-31",{"name":290,"class":43},"University of British Columbia",12,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":16,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":44},"100564134","severe-asthma-network-italy-100564134","NCT06625216","Severe Asthma Network Italy","Observatory of Patients With Severe Asthma and Potential Eligible Patients for Treatment With Biological Drugs","SANI","Inclusion Criteria:\n\n1. signed informed consent and privacy disclaimer;\n2. age \\> 12 years;\n3. diagnosis of severe asthma according to the ERS\u002FATS criteria:\n\n   1. During treatment with:\n\n      * High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or\n      * Oral corticosteroids \\>6 months\u002Fyear\n   2. at least one of the following occurs or would occur if treatment would be reduced:\n\n      * ACT \\\u003C20 or ACQ\\>1.5\n      * At least 2 exacerbations in the last 12 months\n      * At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months\n      * FEV1 \\\u003C80% (if FEV1\u002FFVC below the lower limit of normal)\n\nExclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.","13 Years",{"count":83,"type":21},"The goal of this registry is collecting data of severe asthma patients, recruited by specialized centers, in a real life setting, homogeneously placed on a database management system to follow them over the time.\n\nThe information recorded will provide:\n\n1. The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.\n2. The evaluation of adherence to treatment in real life.\n3. The clinical eligibility of patients treated with biologics.\n4. The evaluation of patients' clinical response to each treatment.\n5. The monitoring of tolerability and safety.\n6. The long-term follow up of patients with severe asthma.",[25],[25,305,306,307,308],"Network","Registry","Biologics","Adherence","2026-04-23",{"date":311,"type":36},"2026-04-29",{"date":313,"type":36},"2017-02-17",{"date":315,"type":21},"2037-02-17",{"name":317,"class":43},"Società Italiana di Allergologia, Asma e Immunologia Clinica",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":328,"conditions":329,"keywords":332,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":235},"100633752","real-world-effectiveness-of-benralizumab-in-allergic-bronchopulmonary-aspergillosis-100633752","NCT07530770","Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis","Effectiveness and Safety of Benralizumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience","Inclusion Criteria:\n\n* Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA:\n\nPredisposing condition: Bronchial asthma Obligatory criteria (both should be present)\n\nType I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af) Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use.\n\nElevated total IgE levels (\\>1,000IU\u002FmL)\\* Other criteria (at least two of three)\n\nPresence of precipitating or IgG antibodies against Af in serum Radiographic pulmonary opacities consistent with ABPA Total eosinophil count \\>500 cells\u002FuL in steroid naïve patients (may be historical)\n\n(if the patient meets all other criteria, an IgE value \\\u003C1,000 IU\u002FmL may be acceptable) Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1\n\nOther acceptable asthma controllers include long acting bronchodilators (e.g. a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), a leukotriene inhibitor, theophylline preparations and\u002For maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control Documented current treatment with high daily doses of ICS ( \\>500ug of FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1\n\nFor ICS\u002FLABA combination preparation, highest-strength maintenance doses approved in the U.S. will meet this criterion If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose for 3 months prior to entering the study.\n\nHistory of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days.\n\nWeight \\> 40kg\n\nExclusion Criteria:\n\n* Clinical important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (ie. chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoid, and pulmonary fibrosis) History of anaphylaxis to any biologic therapy Known history of allergy or hypersensitivity reaction to benralizumab or any of its components Current smokers or former smokers with a smoking history of \\> 10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1.\n\nCurrently pregnant, breastfeeding, or lactating women Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.","75 Years",{"count":327,"type":21},20,"An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis",[330,25,331],"Allergic Bronchopulmonary Aspergillosis","ABPA",[331,333],"Benralizumab","2026-04-16",{"date":336,"type":36},"2026-04-21",{"date":338,"type":36},"2025-09-01",{"date":340,"type":21},"2026-12-01",{"name":342,"class":43},"Qianfoshan Hospital",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":44},"100618162","remission-in-adults-with-severe-asthma-in-thailand-100618162","NCT07328035","Remission in Adults With Severe Asthma in Thailand","Inclusion Criteria:\n\n* severe asthma\n* age 18 years or older\n\nExclusion Criteria:\n\n* inability to perform spirometry or fractional exhaled nitric oxide (FeNO) test",{"count":350,"type":21},230,"The goal of this observational study is to determine the prevalence of remission among adults with severe asthma, as well as the factors associated with remission in Thailand.\n\nThe main question the study aims to answer is:\n\nWhat is the prevalence of remission among adults with severe asthma in Thailand? Participants will complete questionnaires on asthma symptoms and undergo pulmonary function testing and a blood test once.",[25,353],"Asthma Control Level",[355,356,357,358,359,360],"asthma","remission","Thailand","severe","FeNO","blood eosinophil count",{"date":362,"type":36},"2026-04-17",{"date":364,"type":36},"2026-01-01",{"date":366,"type":21},"2026-12-31",{"name":368,"class":43},"Thammasat University",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":377,"targetDuration":4,"studyType":57,"phases":379,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100633867","phase-2-a-phase-2-clinical-study-to-evaluate-the-efficacy-and-safety-of-frevecitinib-kn-002-in-patients-with-severe-asthma-100633867","NCT07532265","A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma","A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients With Severe Asthma","PANAIRAMA","Inclusion Criteria:\n\nCapable of understanding the written informed consent, provides signed and witnessed written informed consent prior to any study-related procedures, and agrees to comply with protocol requirements.\n\nBody mass index between 18 to 40 kg\u002Fm2 and weight ≥40 kg at screening.\n\nDocumented physician-diagnosed asthma for at least 12 months prior to screening.\n\nHas received a physician-prescribed asthma controller regimen with medium dose or high dose ICS plus LABA, with or without additional controller medications for at least 6 months prior to screening and the dose of ICS and additional controller(s) must be stable for at least 4 weeks prior to screening and throughout the screening\u002Frun-in period.\n\nHas a pre-bronchodilator FEV1 value of ≥40% and ≤80%, predicted, at screening and at Day 1.\n\nHas a post-bronchodilator reversibility of FEV1 ≥12% and ≥200 mL documented during screening (15 to 30 min after administration of 4 puffs of albuterol\u002Fsalbutamol).\n\nHas an ACQ-6 score of ≥1.5 during screening (ie, Visit 1 and Visit 2).\n\nHas a documented history of at least 1 asthma exacerbation in the 12 months prior to the screening visit, while using medium to high dose ICS\u002FLABA therapy\n\nAcceptable inhaler, peak flow meter, and spirometry techniques during the screening\u002Frun-in period.\n\n≥80% compliance with required use of the ePRO device within the last 14 days of the screening\u002Frun-in period.\n\nFemales of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions throughout the study and continue using such precautions for 16 weeks after the final dose of study treatment.\n\nExclusion Criteria:\n\nCurrent smokers or participants with a smoking history of ≥10 pack years\n\nParticipants with a current history of angina or history of myocardial infarction, stroke, or TIAs within the past 12 months from screening are disallowed.\n\nParticipants with a history of pulmonary embolic or thrombotic events, or genetic or autoimmune (eg anti-phospholipid syndrome) predisposition for thrombosis are disallowed.\n\nAny concomitant respiratory disease that, in the opinion of the investigator and\u002For medical monitor, will interfere with the evaluation of the investigational product or interpretation of participant safety or study results\n\nAny clinically relevant abnormal findings in hematology, clinical chemistry, coagulation, or urinalysis (laboratory results from visit), physical examination, vital signs during the screening\u002Frun-in period which, in the opinion of the investigator, may put the participant at risk because of his\u002Fher participation in the study\n\nEvidence of active liver disease including jaundice or AST, ALT, or bilirubin greater than twice the upper limit of normal.\n\nHistory of cancer\n\nParticipants with a respiratory tract infection that has not fully resolved by screening, or who experience an RTI during screening or at Day 1.\n\nEvidence of a clinically significant infection or receiving treatment with systemic antibiotic, anti-parasitic, or antiviral medications at Day 1.\n\nKnown history of active TB or a positive QFT-G test for TB during screening.\n\nA positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C.\n\nA positive human immunodeficiency virus test at screening or participant taking antiretroviral medications, as determined by medical history and\u002For participants verbal report.\n\nHistory of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.\n\nUse of oral or topical JAK inhibitors for any reason or use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot glucocorticoid, or any experimental anti-inflammatory therapy) within 3 months prior to screening and throughout the study.\n\nReceipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and throughout the study.\n\nPrescription of regular daily oral corticosteroids within 4 weeks prior to screening or during the screening\u002Frun-in period and throughout the study.\n\nSystemic glucocorticoid burst including taper within 15 days prior to screening or during the screening\u002Frun-in period and throughout the study.\n\nPrescription of concomitant parenteral monoclonal antibody therapy for the management of asthma or any other condition within a specified period prior to the screening visit\n\nPregnant, breastfeeding, or lactating females.\n\nHistory of chronic alcohol or drug abuse within 12 months prior to screening, as determined by the investigator.\n\nPlanned surgical procedures requiring general anesthesia or in-patient status for \\>1 day during the conduct of the study.\n\nReceipt of any live or attenuated vaccines within 15 days prior to screening.\n\nParticipants who have undergone bronchial thermoplasty.\n\nProlonged QTcF \\>470 ms at screening or baseline.",{"count":378,"type":21},512,[380],"PHASE2","A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) Over a 12-Week Treatment Period in Patients With Severe Asthma Not Controlled With Medium to High Dose ICS\u002FLABA",[25],[384,385],"KN-002 frevecitinib Phase 2 dose ranging","JAK JANUS kinase","2026-04-15",{"date":388,"type":36},"2026-04-20",{"date":390,"type":21},"2026-06-01",{"date":392,"type":21},"2027-11-30",{"name":394,"class":72},"Kinaset Therapeutics Inc",15,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":57,"phases":406,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":235},"100615453","bronchial-thermoplasty-for-adults-with-severe-asthma-in-the-biologic-era-100615453","NCT07292805","Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era","Bronchial Thermoplasty (BT) for Severe Asthma in the Biologic Era: a Randomized Controlled Trial (BOOSTER Trial)","BOOSTER","Inclusion Criteria:\n\n* adult (\\>18 years)\n* severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical therapy (GINA treatment step 5; alternative diseases excluded, therapy compliance and adequate inhalation technique confirmed)\n* 1 or more trials of treatment with a biologic or ineligible for biologic treatment\n* 2 or more severe asthma exacerbations in the previous year (defined as the need for a course of OCS or doubling dose of maintenance OCS for at least 3 consecutive days)\n* FEV1 ≥ 50% predicted after 400μg inhaled salbutamol or equivalent\n\nExclusion Criteria:\n\n* chronic OCS therapy at a dose \\>20 mg\u002Fday prednisone equivalent\n* 1 or more ICU admission for mechanical or endotracheal intubation for\n* asthma in the previous year.\n* anti-coagulation therapy that cannot be stopped temporarily\n* pregnancy\n* body mass index ≥35\n* current or ex-smokers with \\>20 pack years\n* DLCOc \\\u003C70%\n* Subject has a known sensitivity to medications required to perform bronchoscopy\n* Subject is using immunosuppressant therapy other than oral steroid therapy that impact on BT\n* Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000\u002Fmm2 or known coagulopathy\n* Comorbidities that are a contra-indication for BT such as severe heart failure and other respiratory diseases including bronchiectasis, interstitial lung disease, emphy-sema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (ABPA)\n* Subject uses an internal or external pacemaker or cardiac defibrillator..",{"count":405,"type":21},90,[107],"Rationale: For patients with severe asthma that remain uncontrolled with exacerbations despite biologics or patients who are not eligible for biologics, there is no reimbursed treatment other than pulmonary rehabilitation in the Netherlands. Pulmonary rehabilitation is known to have a limited effect for a limited amount of time. Bronchial thermoplasty or bronchial ablation (BT) is a non-pharmacological treatment for asthma aiming to restore abnormal airway function by using an endobronchial approach. Previous RCT's reported efficacy on exacerbations and asthma related quality of life (AQLQ), but were performed before large availability of biologic treatments. Although a single BT treatment is not without costs, these costs seem to outweigh the costs that can be saved by the long-term (\\>5 years) lowering effect of BT on the frequency of exacerbations and hospitalizations and omitting long term use of trials and switches of biologics. Therefore, the investigators hypothesize that BT, in the era of biologics, is superior (in terms of exacerbations and quality of life) over standard care and cost-effective in patients whose asthma remains uncontrolled despite optimal anti-inflammatory treatments including biologics, and the investigators propose to test this hypothesis in a RCT.\n\nObjective: To investigate the impact of BT as compared to standard of care in severe asthma patients that remain uncontrolled despite standard treatment including adequate doses of inhaled preventer therapies with or without biologics on:\n\n1. rate of exacerbations\n2. asthma related quality of life (AQLQ)\n3. 1-year and 5-year cost-effectiveness and cost utility Study design: Investigator-initiated randomized, multicenter, parallel-group interventional RCT of severe asthma patients undergoing either BT (active arm) or standard care (control arm).\n\nStudy population: Adult, uncontrolled severe asthma patients despite optimal medical therapy including one or more trials of treatment with a biologic or ineligible for biologic treatment AND 2 or more severe asthma exacerbations in the previous year AND FEV1 ≥ 50% predicted.\n\nIntervention: BT (active arm) versus standard care (control arm). Main study parameters\u002Fendpoints: The primary endpoint of this study is the between group difference in severe exacerbation rate after 12 months of follow-up. The main secondary endpoints are between group differences after 12 months of follow-up and within group differences before and after intervention or standard care. Parameters that will be explored are: AQLQ (minimal clinically important difference \\>0.5), ACQ (minimal clinically important difference \\>0.5), exacerbation rate (before and after BT) and hospitalizations (rate and % subjects).",[409,25,410],"Asthma Exacerbations","Bronchial Thermoplasty",[412,355,112,413],"bronchial thermoplasty","asthma exacerbations","2025-12-17",{"date":416,"type":36},"2025-12-18",{"date":418,"type":36},"2024-04-09",{"date":420,"type":21},"2029-04-30",{"name":422,"class":43},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":430,"targetDuration":4,"studyType":57,"phases":431,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100440669","phase-2-evaluate-the-efficacy-and-safety-of-fb704a-in-adult-with-severe-asthma-100440669","NCT05018299","Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma","A Randomized, Placebo Controlled, Double Blind Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Multiple Intravenous Doses of FB704A in Adults With Severe Asthma","Inclusion Criteria:\n\n1.18 to ≦75 years of age, either sex, any race. 2.Diagnosed as severe asthma based on 2020 GINA guideline. 3.An ACT score is \\\u003C20. 4.Induced sputum neutrophil count ≧50% of total sputum cells during Screening. 5.Documented diagnosis of severe asthma within past 5 years. Additionally, subjects must have at least one of the following: a) ≧12% and\u002For 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, OR b) airway hyperresponsiveness (e.g., positive methacholine challenge \\\u003C8 mg\u002FmL), OR c) within the past 24 months, airway variability with a ≧12% and 200 mL change in FEV1 between clinic visits outside of respiratory infections, documented prior to Visit 1, OR d) within the past 24 months, average daily PEF variability \\> 10% over a 2-week period, documented prior to Visit 1.\n\n6.Nonsmoker or previous smoker with cumulative smoking history less than 10 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e-cigarettes prior to screening.\n\n7.Must not have had a severe asthma exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening.\n\nA Severe asthma exacerbation is defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.\n\n8.Must be willing to give written informed consent to participate in the study. 9.Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.\n\n10.Female subject of childbearing potential must have a negative serum pregnancy test at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate \\\u003C1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.\n\nMale subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.\n\nExclusion Criteria:\n\n1.Chronic Obstructive Pulmonary Disease (COPD)\u002Fother relevant lung disease (other than asthma) 2.4 weeks prior to\u002For Screening: upper\u002Flower respiratory tract infection 3.Screening: Inadequate amount or difficulty producing sputum 4.Screening: Sputum neutrophil count over 10 million\u002FmL 5.Screening: peripheral blood neutrophil (PBN) count \\\u003C2000\u002FµL 6.Clinically significant chronic infectious disease(s) (eg, Human Immunodeficiency Virus \\[HIV\\], hepatitis B or C) 7.Allergy\u002Fsensitivity to study drug\u002Fexcipients 8.Breast-feeding, pregnant\u002Fintends to become pregnant during study 9.Requiring mechanical ventilation for respiratory event within 6 months of Screening 10.Medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or medication that may interfere with effect of study medication 11.Within 30 days of Screening: any other investigational drug 12.Known history of active tuberculosis (TB) or evidence of tuberculosis infection as defined by a positive purified protein derivative (PPD) skin test and\u002For interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result 13.Active infection, including opportunistic infections, requiring systemic therapy within the past 2 weeks 14.A deep space infection within the past 2 years (including, but not limited to meningitis, epiglottitis, endocarditis, septic arthritis, fasciitis, abdominal or pleural abscess, or osteomyelitis) 15.History of diverticulitis, diverticulosis requiring antibiotic treatment, or other symptomatic lower gastrointestinal (GI) conditions that might predispose to perforations 16.Immunization with a live\u002Fattenuated vaccine within 4 weeks prior to treatment 17.Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured) 18.Liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 3x upper limit of normal 19.Serum bilirubin \\> 2x upper limit of normal 20.Low platelet count (\\\u003C100,000\u002Fmm3) 21.Dyslipidemia. 22.Participation in any other clinical study. 23.Part of the staff personnel involved with the study. 24.Family member of investigational study staff.",{"count":327,"type":21},[380],"This is a randomized, placebo controlled and double blind study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe asthma. The study comprised a 4-week screening period, a 8-week treatment period and a 12-week follow-up period.",[25],[110],"2025-12-02",{"date":437,"type":36},"2025-12-09",{"date":439,"type":36},"2021-09-30",{"date":441,"type":21},"2026-05-08",{"name":443,"class":72},"Oneness Biotech Co., Ltd.",9,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":463,"leadSponsor":465,"locationsCount":44},"100603698","downstream-effects-of-airway-mucus-plugs-on-129xenon-mri-in-severe-asthma-100603698","NCT07139899","Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma","Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy","Inclusion Criteria:\n\n* Adequate completion of informed consent process with written documentation\n* Patients 18 - 65 years old\n* Physician diagnosis of asthma for \\> 1 year\n* Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs within previous 30 days of enrollment\n* All racial\u002Fethnic backgrounds may participate\n* Blood eosinophil count \\> 300 cells\u002FμL\n* Smoking history \\\u003C10 pack years\n* No smoking history (including vapes, cigar, or marijuana use) in the last 3 months\n* About to initiate asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care\n\nExclusion Criteria:\n\n* Respiratory tract infection within the 4 weeks prior to Visit 1\n* Body mass index (BMI) \\> 30 at Visit 1\n* One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1\n* Asthma-related ER visit within the previous 4 weeks of Visit 1 or at any time while on the study\n* Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)\n* Resting O2 saturation \\\u003C90% with maximum supplemental O2 delivered by nasal cannula\n* Positive urine pregnancy test at Visit 1 or at any time while on the study\n* Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study\n* Unable or unlikely to complete study assessments in the opinion of the Investigator\n* Study intervention poses undue risk to patient in the opinion of the Investigator\n* Conditions that will prohibit MRI scanning determined by the MRI safety screening.",{"count":453,"type":21},5,"In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.",[25],[457,355,458],"xenon","mucus","2025-11-17",{"date":461,"type":36},"2025-11-20",{"date":459,"type":36},{"date":464,"type":21},"2027-09",{"name":466,"class":43},"Bastiaan Driehuys",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":44},"100585547","experience-of-biologic-treatments-for-severe-asthma-a-survey-100585547","NCT06903780","Experience of Biologic Treatments for Severe Asthma: a Survey","A Retrospective Survey Of The Time Course And Nature Of The Experience Of Initiating Biologic Treatment For People With Severe Asthma.","SHARP EoB","Inclusion Criteria:\n\nReceiving a biologic treatment for at least 6 months.\n\n• But has not been on the treatment for longer than 18 months. Note: In clinical practice, a 12-month trial of biologic treatments is needed before a decision to stop\u002Fswitch treatment is made. Therefore, our inclusion criteria will capture people who are non-responders to biologic treatments.\n\nExclusion Criteria:\n\n* Patients will be excluded if they are unwilling\u002Funable to provide consent to use their data.\n* Patients who have switched biologics will also be excluded.\n* In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.",{"count":56,"type":21},"Severe asthma is a disease characterised by respiratory and non-respiratory symptoms. The respiratory symptoms can include breathlessness, wheeze and asthma attacks. The disease can come to dominate patients' lives, impacting their social, working and personal lives, leading to depression, anxiety and feelings of social isolation.\n\nThere are now 7 different biologic treatments available on the NHS in the UK for severe asthma. These treatments have dramatically changed how severe asthma can be treated. Research has typically focused on the benefits of these drugs from a clinical perspective, e.g., improvements in lung function, blood tests and reduction in frequency of asthma attacks and use of steroid tablets.\n\nWhile these are important outcomes, they do not reflect the experiences of patients receiving these treatments, which can vary greatly. First, not all patients benefit to the same degree. Second for patients who do respond, some respond slower than others. Third while these treatments target respiratory symptoms, some patients report wider benefits, such as reductions in fatigue, depression, ability to engage in family life and other daily activities. Fourth, patients report different side effects when starting these treatments and sometimes for months afterwards, including headaches, fatigue, mental fog and joint pain. These experiences are reported by clinicians and patients, but the extent of these four variations is poorly understood, and potential reasons for them have not been explored.\n\nTo describe these differences between patients' experiences and begin understanding why they are present, we have co-designed a survey with people who have lived experience of severe asthma who are members of the European Lung Foundation's (ELF) Patient Advisory Group (PAG). This process has resulted in a survey that contains content important to patients and is worded in a way that avoids confusion regarding the meaning of the questions.",[25],[355,479,480,481,482,483],"survey","patient perspectives","patient centred","co-development","multi-centre","2025-06-23",{"date":486,"type":36},"2025-06-27",{"date":488,"type":36},"2025-01-01",{"date":490,"type":21},"2025-12-31",{"name":492,"class":43},"Royal Devon and Exeter NHS Foundation Trust",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":500,"targetDuration":4,"studyType":57,"phases":502,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":4},"100593952","phase-3-potency-of-hdm-sublingual-ait-tablets-in-assuring-the-persistency-of-asthma-control-in-hdm-allergic-patients-with-severe-asthma-treated-with-tezepelumab-100593952","NCT07013123","Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab","TEZEPAIT","Inclusion Criteria:\n\n* Patients aged ≥ 18 years and ≤ 65 years.\n* Patient followed by a specialist in allergy and\u002For respiratory diseases working at one of the investigating sites in France.\n* Patient allergic to HDM and with a clinical history of HDM-allergic asthma.\n* Positive specific IgE (≥ 0.35 kUA\u002FL, ImmunoCAP®) and positive skin prick test for Dermtophagoides pteronyssinus and\u002For Dermtophagoides farinae at screening.\n* Patients satisfying diagnostic criteria for severe asthma, according to GINA international guidelines.\n* A clinical history of asthma exacerbations in the past two years.\n* A history of at least 2 asthma exacerbations during the previous 12 months.\n* Uncontrolled asthma (ACT \\\u003C20\u002F25)\n* Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements.\n* Patients with persistent severe asthma who meet the Marketing Authorization criteria for Tezspire® (Tezepelumab) and Acarizax® prescriptions.\n\nExclusion Criteria:\n\n* Patients sensitized and regularly exposed to animal dander, molds, and\u002For cockroach or any another perennial allergen.\n* Patients treated with a monoclonal antibody for asthma within the previous 3 months or 5 half-lives.\n* Patients who have received Sublingual immunotherapy (SLIT) or Sub-Cutaneous Immunotherapy (SCIT) treatment with DermatophagoIdes pteronyssinus and\u002For Dermatophagoïdes farinae within the previous 5 years.\n* Patients received any education provided by a medical indoor environment counselor during the 12 months before the study, or and educational program is programmed during the study.\n* Patients with acute respiratory tract infections.\n* The patient who have performed any specific measure for mites' avoidance during the 12 months before the study or plan to implement such measures during the study.\n* Pregnant, breastfeeding or lactating women.\n* Patients with a history of tumor, autoimmune, or immune deficiency pathology.\n* Patients with hematological pathology (coagulation disorders, anemia) that could interfere with the blood test.\n* The patient reports any previous hypersensitivity reaction to the active substance or excipients present in Tezspire® or Acarizax®.\n* Patients unable to read and\u002For write French language.\n* Absence of signed consent.\n* Patients who are not beneficiaries of the French social security system.\n* Presence of any condition (physical, psychological or other) that might, in the investigator's opinion, hinder study performance.\n* The patient is unavailable or unwilling to participate in future visits or is unable to comply with trial protocol.\n* Women of childbearing potential and fertile men not using effective contraception.\n* The patient is participating in another study for asthma and\u002For allergy treatment.\n* Patients in an exclusion period determined by a previous study or is currently participating to any other allergy\u002Fasthma trial.\n* Patients under legal protection (guardianship or curatorship)\n* Patients with a business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial.",{"count":501,"type":21},38,[59],"The aim of this drug trial is to evaluate the annualized asthma exacerbation rate under treatment with Acarizax versus placebo. The trial is intended for adults aged 18 to 65 with severe uncontrolled asthma and a house dust mite allergy. The study will involve 32 patients (up to 38 with study dropouts) recruited from French hospitals, in pulmonology and allergology departments.\n\nInitially, all participants will receive Tezepelumab for 3 to 6 months (M-3\u002F-6) to control asthma symptoms. If asthma is not controlled after 6 months, the participant will be excluded from the study and will continue on standard treatment.\n\nOnce their asthma is controlled, patients will be randomized in two groups:\n\n* Group A: Tezepelumab + Acarizax®\n* Group B: Tezepelumab + Placebo After 6 months of treatment with Acarizax or placebo (M6), Tezepelumab will be stopped and participants will continue treatment with Acarizax or placebo alone for a further 12 months (up to M18\u002FEnd of search).\n\nThe study will include 5 visits during regular consultations (M-3\u002FM-6, D0, M6, M12 and M18), as well as 2 follow-up telephone calls M3 and M9).",[25,505],"Allergy to House Dust Mites",[110,507,508],"Dust Mite Allergy","Allergen immunotherapy","2025-06-05",{"date":511,"type":36},"2025-06-10",{"date":513,"type":21},"2025-07-15",{"date":515,"type":21},"2029-08-18",{"name":517,"class":43},"University Hospital, Montpellier",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":16,"minAge":524,"maxAge":4,"enrollmentInfo":525,"targetDuration":527,"studyType":22,"phases":4,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":542},"100361292","swiss-severe-asthma-register-100361292","NCT03984253","Swiss Severe Asthma Register","Inclusion Criteria:\n\n* In- and outpatients\n* Age ≥ 0 year\n* Informed consent as documented by signature\n\nAdults:\n\n\"Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:\n\n* High level therapy:\n\n  1. high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier\u002Ftheophylline) for the previous year or\n  2. Daily long-term therapy with systemic corticosteroids (CS) for ≥50% of the previous year to prevent it from becoming \"uncontrolled\" or which remains \"uncontrolled\" despite this therapy or\n  3. Therapy with monoclonal antibodies independent from the co-therapy\n* Middle level therapy:\n\nProtokollsynopsis SAR Version 01 16.01.2019 Seite 4\u002F10 a) Daily long-term therapy with medium-to high-dose ICS (≥500 μg Beclomethason (powder) or equivalent in combination with LABA or leukotriene modifier\u002Ftheophylline) for the previous year and uncontrolled asthma defined as at least one of the following:\n\n* Poor symptom control: ACQ consistently \\>1.5, ACT \\\u003C20 (or \"not well controlled\" by NAEPP\u002FGINA guidelines).\n* Frequent severe exacerbations: two or more bursts of systemic CS (\\>3 days each) in the previous year.\n* Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year.\n* Airflow limitation: after appropriate bronchodilator withhold FEV1 \\\u003C80% predicted (in the face of reduced FEV1\u002FFVC defined as less than the lower limit of normal).\n* Controlled asthma that worsens on tapering of these high doses of ICS or systemic CS (or additional biologics). The presence of any one of the following exclusion criteria will lead to exclusion of the patients:\n* Life-expectancy \\\u003C6 months\n* Insufficient knowledge of project language\n\nChildren:\n\nThe criteria for severe or difficult asthma in children and adolescents are considered fulfilled in the case of insufficient symptom control in the last year despite medium\u002Fhigh antiinflammatory long-term therapy:\n\n* age 0-18 years, at time of inclusion\n* diagnosis of bronchial asthma made by a physician\n* differential diagnoses excluded\n* good compliance and trained inhalation technique\n* treatment with biological approved for the treatment of severe asthma (currently only omalizumab) or\n\nProof of:\n\na) Positive Bronchodilation-test (≥12% increase in FEV1 after SABA) or b) Significant bronchial hyperresponsiveness after nonspecific provocation (e.g., with Methacholine or treadmill) according to ATS criteria (AJRCCM 2000)\n\n* High level of therapy:\n\n  1. Prolonged therapy with high dose inhaled steroid (ICS) (\\> 400 μg Budesonide equivalent \u002F\\> 200 μg fluticasone alone); or\n  2. Daily long-term therapy with medium- to high-dose ICS (≥ 400 μg Budesonide equivalent \u002F ≥200 μg fluticasone) in combination with long-acting betaagonists and \u002F or leukotriene receptor antagonist and \u002F or theophylline; or\n  3. Therapy with oral steroids fixed ≥3 last months.\n* Insufficient asthma control\n\n  a) Inadequate symptom control after NVL in the last 4 weeks: Protokollsynopsis SAR Version 01 16.01.2019 Seite 5\u002F10\n  * ≥3 x weekly asthma symptoms or use of ondemand medication; Or:\n  * limited activity due to asthma; Or:\n  * any symptoms at night; or b. Exacerbation(s) ≥1 last year that required treatment with systemic steroids and \u002F or inpatient treatment c. limited lung function:\n  * pathological Tiffeneau quotient or FEV1 at inclusion.\n* Submission of a written consent (parent\u002F legal guardian).\n\nExclusion Criteria:\n\n* Life-expectancy \\\u003C6 months · Insufficient knowledge of project language","1 Year",{"count":526,"type":21},600,"15 Years","Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity.\n\nDespite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma.\n\nBased on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death.\n\nSeveral severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods.\n\nApproximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated.\n\nFor all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.",[25],[110,531,532],"Severe","Register","2025-03-10",{"date":535,"type":36},"2025-03-12",{"date":537,"type":36},"2019-05-13",{"date":539,"type":21},"2034-02-28",{"name":541,"class":43},"Prof. Dr. Jörg Leuppi",10,{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":57,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100578955","phase-4-withdrawal-of-dupilumab-in-severe-asthma-100578955","NCT06818019","Withdrawal of Dupilumab in Severe Asthma","WIthdrawal of DUpilumab in Severe Asthma: a Randomized Non-inferiority-controlled Trial","WIDUSA","Inclusion Criteria:\n\n* Adult patients ≥ 18 years old\n* Treated with dupilumab for at least 36 months for severe asthma\n* Well controlled asthma defined by an Asthma Control Questionnaire score ≥ 18 and 0 or 1 exacerbation within the year prior to the inclusion visit\n\nExclusion Criteria:\n\n* Patients who refuse to discontinue dupilumab, for any reason\n* Patients with Forced expiratory volume in one second ≤ 30% of predicted values\n* Patients treated by an oral corticosteroid dose ≥ 10 mg\u002Fday (in prednisone equivalent)\n* Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma\n* Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis\n* Active smoking\n* Pregnancy or breastfeeding",{"count":552,"type":21},205,[133],"Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.",[25],[112,557,558,559],"dupilumab","exacerbation","discontinuation","2025-02-07",{"date":562,"type":36},"2025-02-10",{"date":564,"type":21},"2025-04-02",{"date":566,"type":21},"2029-12-31",{"name":568,"class":43},"University Hospital, Toulouse",29,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":16,"minAge":578,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":44},"100568462","exploring-the-lived-experience-of-young-adults-with-severe-asthma-100568462","NCT06681545","Exploring the Lived Experience of Young Adults With Severe Asthma","An Exploration of the Experiences and Support Needs of Young Adults With Severe and Uncontrolled Asthma","EaSY","Inclusion Criteria:\n\n* A confirmed diagnosis of severe or uncontrolled asthma under the care of the Manchester or Liverpool severe asthma services\n* Participants aged 16-25 years.\n* Informed consent provided.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Participants with additional long-term conditions who identify their dominant health concern to be non-asthma related.\n* Focus group only- inability to converse in English","16 Years","25 Years",{"count":581,"type":21},46,"Asthma is a serious long-term lung condition caused by swollen airways that narrow. This causes wheezing, chest tightness, and breathlessness. Most asthma is well-controlled with medication.\n\nHowever, 5-10% of asthmatics have severe asthma where treatment does not control symptoms and up to 67% of asthmatics have uncontrolled asthma, caused by not always taking medication as recommended, lifestyle choices or other health problems worsening their asthma.\n\nIn the UK, asthma affects around 800,000 young adults. This group is at high-risk of having poor asthma control, worse outcomes than other age-groups. This is because young adults need care that differs from other age-groups and current care is not meeting these needs.\n\nThere is little information on the experiences and needs of this group and very few studies exist, exploring how to improve care. This study will explore the experiences and needs of young adults (age16-25) with severe and uncontrolled asthma.\n\nMethods. The investigators will perform two study-arms with young adults with severe\u002Funcontrolled asthma in Manchester and Liverpool severe asthma centres:\n\nStudy-arm 1: Interview participants using photographs chosen by them to help explain their experiences of living with asthma and support that they need.\n\nStudy arm 2: Perform group interviews to understand participants' thoughts around the insights from study-arm 1 combined with their own experiences. To explore and develop ideas on how to improve future care.\n\nAt the end of both study arms, a workshop involving patients and stakeholders involved in delivering care will take place, to identify a joint goal of how to improve care in this cohort and map ways in which to achieve this.\n\nTogether, the study results and workshop will increase our understanding of the experiences and needs of young adults with asthma. Helping us to identify new ways to improve care which can be tested in future research.",[110,25,584],"Uncontrolled Asthma",[586,587,588],"young people","young adults","young person","2025-02-03",{"date":591,"type":36},"2025-02-05",{"date":593,"type":36},"2024-11-25",{"date":595,"type":21},"2025-10-31",{"name":597,"class":598},"Manchester University NHS Foundation Trust","OTHER_GOV",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":16,"minAge":606,"maxAge":4,"enrollmentInfo":607,"targetDuration":524,"studyType":22,"phases":4,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100518803","register-schweres-asthma---german-asthma-net-ev-100518803","NCT06035289","Register Schweres Asthma - German Asthma Net e.V.","Klinisches Register Schweres Asthma","Definition: Severe asthma in children and adolescents\n\nPoor symptom control in the last year despite (medium to) high doses of anti-inflammatory maintenance treatment:\n\n(i) Age 6-18 years (at inclusion) (ii) Asthma diagnosis made by a medical doctor (iii) Potential differential diagnoses excluded (iv) Good compliance and trained inhalation technique (v) Evidence of:\n\na. Positive bronchodilator reversibility testing (≥ 12% increase in FEV1 after SABA) or b. Significant bronchial hyperreactivity (BHR) after unspecific provocation test (e.g. methacholine challenge or treadmill) according to ATS criteria (Am J Respir Crit Care Med 2000) (vi) High level of treatment:\n\n1. Maintenance treatment with high doses of ICS (\\>400 μg budesonide or equivalent \u002F ≥ 200 μg of fluticasone as monotherapy) or\n2. Maintenance treatment with medium to high doses of ICS (≥400 μg budesonide or equivalent \u002F ≥ 200 μg fluticasone) combined with LABA and\u002For LTRA and\u002For theophylline or\n3. Treatment with oral steroids for ≥ 3 months (vii) Poor asthma control:\n\na. Inadequate symptom in the past 4 weeks: i. asthma symptoms ≥3 x \u002F week or use of rescue medication ≥3 x \u002F week; or ii. activity limitations due to asthma; or iii. any nighttime asthma symptoms; or b. ≥ 1 exacerbation in the last year with ≥ 3 days of OCS treatment or hospitalisation or b. Poor lung function with reduced Tiffeneau index or FEV1 at inclusion (viii) written informed consent (parent or legal guardian)\n\nExclusion criteria:\n\n(i) Diagnosis of other obstructive or systemic pulmonary diseases (e.g. cystic fibrosis, COPD) despite BPD at inclusion (ii) Other congenital lung diseases or pulmonary malformations (iii) Other significant chronic diseases (iv) Congenital or acquired heart defects with significant functional limitations\n\nDefinition: Severe asthma in adults\n\nHigh level of treatment (A), i.e. step 5 of GINA guideline or (B) medium level of treatment and poor symptom control:\n\n(A) High level of treatment:\n\n1. Maintenance treatment with high-dose inhaled corticosteroids (≥ 1000 μg beclomethasone (BDP, powder) or equivalent) in combination with LABA or LTRA or theophylline or\n2. Maintenance treatment with oral corticosteroids (OCS) for ≥3 months independent of other asthma treatments or\n3. Treatment with monoclonal antibodies independent of other asthma treatments\n\nB) Medium level of treatment and poor symptom control:\n\n1. Maintenance treatment with medium to high doses of ICS (≥ 500 μg BDP (powder) or equivalent) in combination with LABA or LTRA or theophylline and\n2. Poor symptom control:\n\n(i) asthma symptoms ≥ 3 x \u002F week or use of rescue medication ≥ 3 x \u002F week; or (ii) activities limited due to asthma; or (iii) any nighttime asthma symptoms; or (iv) ≥ 1 exacerbation in the last year with ≥ 3 days of OCS treatment or (v) FEV1\\\u003C80% of predicted","6 Years",{"count":608,"type":21},4500,"The German Asthma Net e.V. focusses on science and research in patients with severe asthma. This includes, in particular, the optimization of medical care and treatment for patients with severe asthma as well as the elucidation and information. An unavoidable basis for a better understanding of severe asthma is the registration and comprehensive characterization of a large patient population. To date, there are only few reliable data on incidence, prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the German Asthma Net e.V. was established in December 2011 as a clinical registry for patients with severe asthma, initially set up on a national basis.",[25],[306,612],"Biological","2024-10-01",{"date":615,"type":36},"2024-10-02",{"date":617,"type":36},"2011-11-01",{"date":619,"type":21},"2026-11-01",{"name":621,"class":43},"German Asthma Net e.V.",45,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":325,"enrollmentInfo":630,"targetDuration":4,"studyType":57,"phases":632,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":647,"locationsCount":327},"100405906","phase-4-predictive-signature-of-benralizumab-response-100405906","NCT04565483","Predictive Signature of Benralizumab Response","BENRAPRED","Inclusion Criteria:\n\n* Patients between 18 and 75 years old.\n* Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.:\n\n  * asthma requiring high doses of ICS (\\>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and\u002For systemic corticosteroids to be controlled over one year,\n  * and\u002For uncontrolled asthma despite the later medications,\n  * and\u002For a controlled asthma worsening after decreasing medications,\n* Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200 milliliter\n* ACQ-7 score ≥ 1,5 at M0.\n* ≥ 3 exacerbations in the 12 months prior to screening visit M-1.\n* Eosinophil blood count ≥ 0,3 G\u002FL at inclusion visit or in the 12 months prior to the inclusion visit. If eosinophil blood count is ≥ 0,15 G\u002FL and \\\u003C 0,3 G\u002FL, an eosinophilic phenotype defined by at least 1 of the following criteria will be required:\n\n  * Fractional Exhaled Nitric Oxide (FeNO) \\> 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit.\n  * Sputum eosinophils ≥ 3% at inclusion visit or in the 12 months prior to the inclusion visit.\n* Patients who provide written informed consent prior to participation in the study\n\nExclusion Criteria:\n\n* Patients diagnosed with difficult-to-treat asthma and\u002For with uncontrolled asthma differential diagnosis according to the judgment of the investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNECH, asthma\u002FCOPD overlap syndrome).\n* Non-adherent patients to inhaled treatment (ICS + LABA).\n* Active smokers or former smokers exceeding 20 packs year.\n* Exacerbation at inclusion visit M0.\n* Active malignancy or malignancy in remission over less than 5 years.\n* Active parasitic infection or parasitic infection in the past 24 weeks.\n* Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20)\n* Patients requiring other immunosuppressive and immunomodulator drugs\n* Patients requiring other biotherapy than Benralizumab, with or without French's marketing authorisation in severe asthma\n* Patients requiring other biotherapy than Benralizumab that affects the immune system\n* SARS-COV2 infection\n* Pregnancy, lactation, or patients with childbearing potential refusing efficient contraceptive method.\n* Patients under psychiatric condition altering their comprehension and their ability to give informed consent.\n* Patients already enrolled in a clinical interventional research.\n* Patients not affiliated to a health insurance plan\n* Patients under guardianship, curators or safeguard of justice",{"count":631,"type":21},220,[133],"The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients.\n\nThis trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)",[635,25],"Asthma; Eosinophilic",[112,637,638,639,640],"therapeutic monoclonal antibody","personalized medicine","transcriptomic","biomarkers","2024-04-25",{"date":643,"type":36},"2024-04-26",{"date":645,"type":36},"2021-10-11",{"date":232,"type":21},{"name":648,"class":43},"Nantes University Hospital"]