[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419597":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":58,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab","ACTIVE_COMPARATOR","Two injections of Dupilumab will be administered at Week 0\u002FVisit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.",[13],"Drug: Dupilumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Two injections of placebo will be administered at Week 0\u002FVisit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg\u002FmL in glass pre-filled syringe to deliver 200 mg in 1.14mL.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).",[15],[30],"Sucrose",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"John Moore","CONTACT","412-648-6726","mooreja6@upmc.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The University of Pittsburgh Asthma Institute at UPMC","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-79.99589,40.44062,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":25,"email":56},"Sally Wenzel, MD","412-647-9955","swenzel@pitt.edu",{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Sally E. Wenzel MD","Professor","100419597","phase-4-measuring-the-effect-of-dupilumab-treatment-on-mucociliary-clearance-mcc-in-subjects-with-moderate-to-severe-asthma-100419597",false,"NCT04743791","Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma","A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma","Inclusion Criteria:\n\n* Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \\\u003C90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller\n* Age \\> 18\n* Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)\n* Reversibility \\>\u002F= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening\n* FEV1\u002FForced Vital Capacity (FVC)\\\u003C75%\n* Blood Eosinophils (EOS) \\>300 cells per mm3\n* Exhaled Nitric Oxide (FeNO) \\>25 parts per billion (ppb)\n* Asthma Control Test (ACT) score \\\u003C20\n\nExclusion Criteria:\n\n* Pregnant, nursing, or unwilling to test for pregnancy\n* Current smoker or \\>10 pack year smoking history\n* Body Mass Index (BMI)\\>37\n* Respiratory infection in the last 30 days\n* Use of antibiotics or oral prednisone in the last 30 days\n* Current or previous use of dupilumab\n* Current or recent use of anti-IL-5 therapies\n* Any other criteria that place the subject at unnecessary risk\n* Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)\n* History of non-skin cell cancer in the last 5 years\n* Drug or alcohol addiction in the last 5 years\n* Any other uncontrolled disease","ALL","18 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.",[79],"Asthma","2026-08-05",{"date":82,"type":83},"2026-08-06","ACTUAL",{"date":85,"type":83},"2022-10-17",{"date":87,"type":73},"2028-06",{"name":60,"class":6},1]