[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655782":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":28,"studyPopulation":17,"armGroups":29,"interventions":41,"overallOfficials":17,"centralContacts":17,"locations":51,"responsibleParty":91,"collaborators":93,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":17,"enrollmentInfo":111,"targetDuration":17,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":54,"whyStopped":17,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"COPD Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Transition Dyspnea Index","Measurement of dyspnea","28 (+\u002F- 2) days",[14],{"measure":15,"description":16,"timeFrame":12},"FEV1 and FVC","Changes in lung function",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Randomized to continue handheld therapy or switch to nebulized delivery","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"SINGLE","DELIVERY is an open-label study with an outcomes assessor blinded to treatment arm.",[27],"OUTCOMES_ASSESSOR","In stable out-patients with an established diagnosis of severe to very severe COPD the hypothesis is that delivery of similar long-acting, maintenance medications via a breath-enhanced jet nebulizer provides significant improvements in ratings of dyspnea and health status compared with continuing therapy with handheld device(s).\n\nThis hypothesized benefit could be due to:\n\nPatients with severe to very severe COPD may not consistently use their handheld inhaler(s) correctly every day and therefore not achieve optimal bronchodilation\u002Fsymptom benefit; and\u002For A breath-enhanced jet nebulizer can deliver smaller size particles and a greater fine particle fraction (\\\u003C 5 μm) than handheld therapy in patients with COPD using Acceptable technique.",[30,35],{"label":31,"type":6,"description":32,"interventionNames":33},"Handheld Inhaler Group","Subjects continue with their current maintenance handheld inhaler regimen",[34],"Device: Continue handheld therapy",{"label":36,"type":37,"description":38,"interventionNames":39},"Nebulizer Group","ACTIVE_COMPARATOR","Subjects switched to nebulized therapy using similar medication solutions",[40],"Device: Nebulized therapy of similar medication solutions",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":17},"DEVICE","Nebulized therapy of similar medication solutions","LABA\u002FLAMA or LABA\u002FLAMA\u002FICS nebulized solutions",[36],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":17},"Continue handheld therapy","Continue with current handheld LABA\u002FLAMA or LABA\u002FLAMA\u002FICS therapy",[31],[52,74],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Midwest Chest Consultants, P.C.","RECRUITING","Saint Charles","Missouri","63301","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-90.48123,38.78394,{"lat":64,"lon":63},[67,72],{"name":68,"role":69,"phone":70,"phoneExt":17,"email":71},"Thomas M Siler, MD","CONTACT","636-946-1650","thomas.siler.md@midwestchest.com",{"name":73,"role":69,"phone":17,"phoneExt":17,"email":17},"Krista Muller, CCRC",{"facility":75,"status":54,"city":76,"state":77,"zip":78,"country":58,"countryCode":59,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Southeastern Research Center","Winston-Salem","North Carolina","27103",{"type":61,"coordinates":80},[81,82],-80.24422,36.09986,{"lat":82,"lon":81},[85,89],{"name":86,"role":69,"phone":87,"phoneExt":17,"email":88},"Benjamin Bregman, MD","336-659-8414","bbregman@southeasternresearchcenter.com",{"name":90,"role":69,"phone":17,"phoneExt":17,"email":17},"Karen McCutcheon, BS, CRCC",{"type":92,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[94,97,100],{"name":95,"class":96},"Viatris Specialty LLC","INDUSTRY",{"name":98,"class":99},"PARI Respiratory Equipment, Inc.","UNKNOWN",{"name":101,"class":96},"Theravance Biopharma","100655782","phase-4-nebulizer-versus-handheld-maintenance-therapy-for-patients-with-copd-100655782",false,"NCT07816835","Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD","DELIVERY","Inclusion Criteria:\n\n* \\> 10 pack-years smoking cigarettes\n* Diagnosis of COPD based on GOLD Criteria\n* Patients are clinically stable for the past 4 weeks\n* Prior Pulmonary function tests showing FEV1 \\\u003C 50% predicted (either 30 minutes post albuterol or within 2-4 hours after using their maintenance long-acting inhaler) within the past 12 months.\n* Currently using a single pMDI or a single DPI with either LABA\u002FLAMA or LABA\u002FLAMA\u002FICS therapy for at least one month.\n\nExclusion Criteria:\n\n* Current diagnosis of dementia or known cognitive impairment.\n* Current impairment in manual dexterity (i.e., severe rheumatoid arthritis, severe tremor, etc)\n* Exacerbation of COPD within the last 2 months\n* Current diagnosis of other respiratory disease including asthma, treatment with a LABA\u002FLAMA slow mist inhaler or treatment with SABA\u002FSAMA nebulizer medications 3-4 times per day as maintenance therapy\n* Current use of daily Prednisone as treatment for COPD","ALL","60 Years",{"count":112,"type":113},120,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","Multi-site, randomized controlled trial to determine whether patients who report NO symptomatic benefit with their maintenance hand-held inhaler(s), benefit upon switching to nebulized therapy using comparable classes of medications.",[119,120],"COPD (Chronic Obstructive Pulmonary Disease)","Chronic Obstructive Pulmonary Disease (COPD)",[122,123,124,125,126],"COPD, BDI, TDI","COPD maintenance therapy","Nebulizer therapy","LABA\u002FLAMA","LABA\u002FLAMA\u002FICS","2026-09-08",{"date":129,"type":130},"2026-09-14","ACTUAL",{"date":132,"type":130},"2026-07-14",{"date":134,"type":113},"2027-06",{"name":5,"class":6},2]