{"id":"gsk573719-gw642444-inhalation-powder","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Nasopharyngitis"}]},"_chembl":{"chemblId":"CHEMBL2109052","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"GSK573719 (umeclidinium) blocks muscarinic M3 receptors on airway smooth muscle, preventing acetylcholine-induced bronchoconstriction. GW642444 (vilanterol) activates beta-2 adrenergic receptors, causing bronchodilation. 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GSK573719/Vilanterol (125/25mcg) and Components in COPD","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1493},{"nctId":"NCT01817764","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":707},{"nctId":"NCT01879410","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-06-13","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":700},{"nctId":"NCT01822899","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-04-04","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":717},{"nctId":"NCT01491802","phase":"PHASE3","title":"Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD","status":"COMPLETED","sponsor":"Queen's University","startDate":"2012-01","conditions":"COPD","enrollment":17},{"nctId":"NCT01691547","phase":"PHASE1","title":"A Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol in Healthy Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-12-17","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":44},{"nctId":"NCT01521377","phase":"PHASE1","title":"QTc Study GSK573719+GW642444","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-12-19","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":100},{"nctId":"NCT01894386","phase":"PHASE1","title":"Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-07-15","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":48},{"nctId":"NCT01636713","phase":"PHASE3","title":"A 24-week Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-07","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":581},{"nctId":"NCT01376388","phase":"PHASE3","title":"Long-term Safety Study for GSK573719/GW642444 in Japanese","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-08","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":131}],"_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":"GSK573719/GW642444 Inhalation Powder","genericName":"GSK573719/GW642444 Inhalation Powder","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"GSK573719/GW642444 is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 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Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}