[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asthma-eosinophilic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asthma-eosinophilic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,72,94,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100553643","phase-3-sim0718-treatment-of-asthma-clinical-study-100553643",false,"NCT06488755","SIM0718 Treatment of Asthma Clinical Study","A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SIM0718 in Adults and Adolescents With Asthma","Inclusion Criteria:\n\n* Age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months；\n* Currently receiving medium- to high-dose inhaled corticosteroids (ICS) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization；\n* Pre-bronchodilator (trough) FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ；\n* Positive bronchodilator response within 12 months prior to randomization or during the screening period;\n* Asthma Control Questionnaire (ACQ-5) score ≥ 1.5;\n* At least one severe asthma exacerbation within 12 months prior to the screening visit and no occurrence within 28 days prior to randomization;\n* Based on the investigator judgment, the subject demonstrates acceptable inhaler, peak flow meter, and spirometry techniques;\n* Compliance with usual asthma controller use ≥ 80% based on the patient diary in 7 days prior to dosing;\n* Voluntarily participate in this clinical study and sign the informed consent form and be able to comply with the clinical visit schedule and study-related procedures;\n* Female subjects of childbearing potential who are sexually active with non-sterilized male partners, male subjects, and their female partners of childbearing potential agree to use adequate and effective contraception throughout the study;\n\nExclusion Criteria:\n\n* Current respiratory disease that may impair lung function as judged by the investigator;\n* Diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy;\n* Within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection;\n* Has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection;\n* History of active tuberculosis; or untreated latent tuberculosis or tuberculosis not receiving standard treatment, unless the investigator judges that the patient has been adequately treated;\n* People with hepatitis B, hepatitis C, or HIV infection;\n* History of malignancy;\n* Major surgery within 8 weeks prior to signing the informed;\n* Bronchial thermoplasty within 12 months prior to randomization;\n* Treatment of systemic glucocorticoid during 4 weeks prior to signing informed to randomization;\n* Previous use or ongoing use of systemic immunosuppressants or biologics for the treatment of autoimmune or inflammatory diseases in 8 weeks or 5 half-lives prior to randomization;\n* Within 16 weeks or 5 half-lives prior to randomization, received a biologic agent with the same therapeutic purpose;\n* Participated in an interventional clinical trial of any drug or medical device within 3 months or 5 half-lives prior to randomization;\n* Poor response to or intolerance to prior anti-IL-4Rα antibody therapy;\n* Within 3 months prior to randomization, received specific immunotherapy；\n* Receipt of intravenous human immunoglobulin (IVIG) or blood products within 30 days prior to randomization;\n* Vaccination with live(attenuated) vaccine within 30 days prior to randomization or plan to receive live (attenuated) vaccine during the study;\n* Are using concomitant medications or treatments that are prohibited in the protocol;\n* The following laboratory abnormalities occurred during the screening period: eosinophils≥1500 cells\u002Fmm3 or 1.5×109\u002FL; Platelets≤80,000 cells\u002Fmm3 or 80×109\u002FL; phosphocreatine kinase (CPK) ≥5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≥3-fold ULN; aspartate aminotransferase (AST)≥ 3-fold ULN; Bilirubin ≥ 2x ULN;\n* History of alcohol abuse or drug abuse within 12 months prior to randomization;\n* Current smokers, or those who have been smoking in recent 6 months, or former smokers who have not been smoking for 6 months with a smoking history of ≥10 pack years;\n* Allergy to L-histidine, trehalose, or Tween 80, or history of systemic hypersensitivity to any biologic products;\n* Females of childbearing potential have a positive pregnancy test result during the screening period; Females planning to become pregnant or breastfeeding;\n* Any clinically significant examination abnormality or serious and\u002For uncontrolled disease that, in the opinion of the investigator, may affect the subject safety, or affect the evaluation of efficacy, or preclude the subject completion of the entire study.","ALL","12 Years","75 Years",{"count":20,"type":21},418,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Phase III clinical study of SIM0718 asthma",[27],"Asthma; Eosinophilic","RECRUITING","2026-03-29",{"date":31,"type":32},"2026-04-02","ACTUAL",{"date":34,"type":32},"2024-06-23",{"date":36,"type":21},"2027-09-30",{"name":38,"class":39},"Simcere Pharmaceutical Co., Ltd","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":40},"100606373","reverse-lung-airway-and-vascular-remodeling-in-asthma-remission-renorm-100606373","NCT07174713","REverse LuNg Airway and Vascular RemOdeling in Asthma ReMission (ReNORM)","ReNORM","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all the following criteria:\n\n1. Participant understands study procedures and is willing to participate in the study as indicated by the patient's signature.\n2. Provision of written, informed consent prior to any study specific procedures.\n3. Males and females aged 18 to 80 years.\n4. Either diagnosed with severe asthma (GINA Step 5) and newly eligible for biologic therapy (based on ACQ-5, current treatment, exacerbation history, and blood eosinophils in accordance with approved criteria for omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab), or a healthy volunteer with no history of chronic lung disease, matched by age and sex. Healthy participants must have a lifetime combustible tobacco and\u002For cannabis (including vaping) consumption of ≤5 pack-years.\n5. Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:\n\n   1. True sexual abstinence\n   2. A vasectomized sexual partner\n   3. Implanon®\n   4. Female sterilization by tubal occlusion\n   5. Effective intrauterine device (IUD)\u002Flevonogestrel intrauterine system (IUS)\n   6. Depo-Provera™ injections\n   7. Oral contraceptive\n   8. Evra Patch™\n   9. Nuvaring™\n6. Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and 8 weeks after last dose of study drug, with negative urine pregnancy test result at Visit 1-5.\n7. Male participants who are sexually active must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until 8 weeks after last dose\n\nExclusion Criteria:\n\nParticipants fulfilling any of the following criteria are not eligible for inclusion in this study:\n\n1. Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and\u002For ear implants) (at the discretion of the MRI Technologist).\n2. In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.\n3. Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.\n4. Participant is unable to perform spirometry or plethysmography maneuvers.\n5. Participant is unable to perform MRI and CT breath-hold maneuvers.",true,"18 Years","80 Years",{"count":52,"type":21},200,[54],"NA","In this program of research, the investigators aim to answer the question: In patients with asthma aged 18-80, how do the lung airways and vessels respond to biologic therapy and what role does age and asthma duration have in this response? While about 4.6 million Canadians live with asthma, \\~5-10% of patients have severe asthma meaning that multiple inhaled and systemic oral corticosteroid treatments have failed to improve symptoms and exacerbations, leading to lost work and school days and substantially diminished ability to participate in normal life. For such people, the vast majority of whom are middle aged and remember asthma as part of their entire lifespan, biologic immunomodulator therapies, which block the function of asthma inflammatory pathways, provide a final step-up therapy option. There is emerging evidence that prescribed in the right patient at the right time, the right biologic can result in clinical remission of asthma. While spontaneous clinical remission of asthma is rare, it has been documented in children in whom lung growth and remodeling is still possible. It remains unknown whether clinical remission in adults is accompanied by the reversal of pathologic remodeling, at the level of the airways and pulmonary vessels. This is critical to elucidate as investigators and physicians move forward with currently proposed criteria for \"complete asthma remission\". The inconvenient truth about asthma and age is that in older adult lungs, exposed to years of infection, exacerbations, smooth muscle remodeling and pulmonary vascular shunt, the mechanisms by which complete pathologic remission may be achieved are complex and poorly understood.\n\nTo address this knowledge gap, the investigators will evaluate 150 patients (Vancouver, Ottawa, Hamilton, London) (in three age tertiles 18-29; 30-59; 60-80) with severe asthma and 50 age- and sex matched healthy volunteers over 2-years using chest CT, MRI and pulmonary function tests. The investigators will use the pulmonary imaging measurements to generate an imaging-index of normal airway structure and function which will be compared with and significantly correlate with MR-guided bronchoscopic sample measurements made before and after 1-\u002F2-years of treatment. The investigators will reveal the pathobiologic relationship between age, asthma duration, clinical remission and imaging normalization with direct comparison to histology-based airway measurements.",[27],[58,59,60,61],"Hyperpolarized Xenon MRI","Clinical Remission","Biologic Therapy","Airway Remodeling","NOT_YET_RECRUITING","2025-09-08",{"date":65,"type":32},"2025-09-16",{"date":67,"type":21},"2025-10",{"date":69,"type":21},"2030-10",{"name":71,"class":39},"Western University, Canada",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100568067","homeostatic-roles-of-eosinophils-in-asthma-100568067","NCT06676397","Homeostatic Roles of Eosinophils in Asthma","Characterization of the Homeostatic Functions of Eosinophils in Asthma: An Exploratory Study","HOMEOS","Inclusion Criteria:\n\n* Patients diagnosed with mild asthma with severe asthma (Biologic-naïve, responders to anti-eosinophil biologic therapies and resistant to anti-eosinophil biologic therapies), control subjects without asthma\n* Signature of informed consent\n* Affiliation with the French social security system\n\nExclusion Criteria:\n\n* Non-eosinophilic asthma\n* Coexistence of a chronic eosinophilic inflammatory condition other than asthma\n* Other respiratory conditions (cystic fibrosis, COPD, allergic bronchopulmonary aspergillosis, etc.)\n* Treatment with corticosteroids within 10 days prior to inclusion\n* Active smoking or a smoking history of more than 20 pack-years\n* Pregnant women\n* Legal incapacity or limited legal capacity\n* Subject unlikely to cooperate with the study and\u002For with anticipated low cooperation as assessed by the investigator\n* Subject without health insurance\n* Subject currently in an exclusion period of another study or as indicated by the \"national registry of volunteers.\"",{"count":81,"type":21},100,[54],"The HOMEOS study is an exploratory, observational, and monocentric research. It focuses on characterizing the homeostatic roles of eosinophils in severe asthma. The primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. The study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .",[27],"2024-11-04",{"date":87,"type":32},"2024-11-06",{"date":89,"type":21},"2024-12-04",{"date":91,"type":21},"2027-02-04",{"name":93,"class":39},"Centre Hospitalier Universitaire de Besancon",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"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":102,"type":21},220,[104],"PHASE4","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)",[27,107],"Severe Asthma",[109,110,111,112,113],"severe asthma","therapeutic monoclonal antibody","personalized medicine","transcriptomic","biomarkers","2024-04-25",{"date":116,"type":32},"2024-04-26",{"date":118,"type":32},"2021-10-11",{"date":120,"type":21},"2026-11",{"name":122,"class":39},"Nantes University Hospital",20,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":40},"100536880","phase-1-nasal-inflammation-following-endotoxin-challenge-in-patients-with-asthma-100536880","NCT06270576","Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma","Nasal Endotoxin Challenge to Study Mucosal Inflammation in Patients With Asthma","Nasal-LPS","Inclusion Criteria:\n\n* Participants will have asthma diagnosed by a health care provider. Healthy controls are individuals without asthma.\n* Written informed consent\n\nExclusion Criteria:\n\n* Current or recent illness (in the past 4 weeks)\n* Recent asthma exacerbation (past 4 weeks)\n* History of nasal perforation or nasal surgery\n* Nasal polyposis\n* Presence or prior history of cardiac or systemic disease\n* Bleeding disorder, use of systemic anticoagulants, or antiplatelet therapy\n* Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants excluding corticosteroids)\n* Use of tobacco or marijuana in the past 2 months or greater than a 10 pack-year smoking history\n* Currently pregnant or breastfeeding",{"count":133,"type":21},60,[135],"PHASE1","A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma.",[27,138],"Asthma","2024-02-13",{"date":141,"type":32},"2024-02-21",{"date":143,"type":21},"2024-04",{"date":145,"type":21},"2028-06",{"name":147,"class":39},"National Jewish Health"]