{"id":"placebo-breath-actuated-inhaler","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a breath-actuated inhaler device formulated without any active drug substance, designed to match the physical and sensory characteristics of an active comparator inhaler. It is used in Phase 3 clinical trials to provide a placebo control arm, allowing researchers to isolate the therapeutic effect of an active treatment from placebo response and device-related effects.","oneSentence":"A placebo inhaler device that delivers no active pharmaceutical ingredient, used as a control comparator in clinical trials.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:26:37.461Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Clinical trial control/comparator (not a therapeutic indication)"}]},"trialDetails":[{"nctId":"NCT05898984","phase":"PHASE1","title":"Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-04-24","conditions":"Asthma","enrollment":69},{"nctId":"NCT00394355","phase":"PHASE4","title":"Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-09","conditions":"Asthma","enrollment":566},{"nctId":"NCT05168644","phase":"PHASE1","title":"Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects","status":"COMPLETED","sponsor":"TFF Pharmaceuticals, Inc.","startDate":"2021-11-14","conditions":"Healthy","enrollment":40},{"nctId":"NCT00085774","phase":"PHASE3","title":"Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2004-06-30","conditions":"Exercise-induced Bronchospasm","enrollment":24},{"nctId":"NCT04576325","phase":"PHASE1","title":"Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma","status":"COMPLETED","sponsor":"TFF Pharmaceuticals, Inc.","startDate":"2020-11-15","conditions":"Asthma","enrollment":17},{"nctId":"NCT02031640","phase":"PHASE3","title":"A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2013-12","conditions":"Asthma","enrollment":1113},{"nctId":"NCT02040779","phase":"PHASE3","title":"A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2013-12-26","conditions":"Persistent Asthma","enrollment":273},{"nctId":"NCT02203474","phase":"PHASE2","title":"A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease","status":"WITHDRAWN","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2014-08","conditions":"Chronic Obstructive Pulmonary Disease, COPD","enrollment":""},{"nctId":"NCT02040766","phase":"PHASE3","title":"A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2013-12","conditions":"Asthma","enrollment":628},{"nctId":"NCT02513160","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2015-09-30","conditions":"Persistent Asthma","enrollment":713},{"nctId":"NCT04872231","phase":"PHASE1","title":"Single Ascending Dose and Multiple Ascending Dose Study of Voriconazole Inhalation Powder in Healthy Adult Subjects","status":"COMPLETED","sponsor":"TFF Pharmaceuticals, Inc.","startDate":"2019-11-22","conditions":"Healthy","enrollment":65},{"nctId":"NCT01194700","phase":"PHASE4","title":"Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers","status":"COMPLETED","sponsor":"Brian J Lipworth","startDate":"2009-11","conditions":"Asthma","enrollment":19},{"nctId":"NCT01739387","phase":"","title":"A Study Assessing Patient Handling of Flutiform® Breath-Actuated Inhaler (BAI) and Flutiform® Pressurised Metered Dose Inhaler (pMDI)","status":"COMPLETED","sponsor":"Mundipharma Research Limited","startDate":"2012-11","conditions":"Asthma, COPD","enrollment":332}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Placebo breath-actuated inhaler","genericName":"Placebo breath-actuated inhaler","companyName":"Teva Branded Pharmaceutical Products R&D, Inc.","companyId":"teva-branded-pharmaceutical-products-r-d-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A placebo inhaler device that delivers no active pharmaceutical ingredient, used as a control comparator in clinical trials. Used for Clinical trial control/comparator (not a therapeutic indication).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}