{"id":"aclidinium-bromide-formoterol-fumarate-combination","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Cough"}]},"_chembl":{"chemblId":"CHEMBL3989798","moleculeType":"Small molecule","molecularWeight":"840.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aclidinium bromide is a muscarinic M3 receptor antagonist that blocks acetylcholine-induced bronchoconstriction, while formoterol fumarate is a beta-2 adrenergic agonist that stimulates bronchodilation. Together, these complementary mechanisms provide sustained bronchodilation and improved lung function in COPD patients. The combination allows for twice-daily dosing with enhanced efficacy compared to monotherapy.","oneSentence":"Aclidinium bromide and formoterol fumarate work together as a long-acting anticholinergic and long-acting beta-2 agonist to relax airway smooth muscle and improve airflow in chronic obstructive pulmonary disease.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:17:18.384Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD) maintenance treatment"}]},"trialDetails":[{"nctId":"NCT03022097","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2017-02-02","conditions":"COPD","enrollment":1625},{"nctId":"NCT03290287","phase":"","title":"Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2017-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":26839},{"nctId":"NCT03662711","phase":"PHASE4","title":"Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease","status":"TERMINATED","sponsor":"Università degli Studi di Ferrara","startDate":"2018-11-11","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":843},{"nctId":"NCT03276078","phase":"PHASE2","title":"Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2017-11-23","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":20},{"nctId":"NCT02552160","phase":"","title":"DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-09-24","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":3732},{"nctId":"NCT02796677","phase":"PHASE3","title":"AMPLIFY - D6571C00001 Duaklir USA Phase III Study","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2016-07-05","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1595},{"nctId":"NCT02424344","phase":"PHASE4","title":"Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-04-27","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":267},{"nctId":"NCT03333018","phase":"","title":"A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-07-06","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":22155},{"nctId":"NCT03181880","phase":"PHASE4","title":"To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease","status":"WITHDRAWN","sponsor":"AstraZeneca","startDate":"2017-12-04","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":""},{"nctId":"NCT00706914","phase":"PHASE2","title":"Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2008-06-30","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":156},{"nctId":"NCT01437540","phase":"PHASE3","title":"Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-09-19","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":590},{"nctId":"NCT01572792","phase":"PHASE3","title":"Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2012-04","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":921},{"nctId":"NCT02165826","phase":"PHASE3","title":"Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2014-05-01","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":1323},{"nctId":"NCT01437397","phase":"PHASE3","title":"Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-09","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1692},{"nctId":"NCT01049360","phase":"PHASE2","title":"Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-12","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":128},{"nctId":"NCT01078623","phase":"PHASE2","title":"Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2010-02","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":176},{"nctId":"NCT01462942","phase":"PHASE3","title":"Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-10","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":2443},{"nctId":"NCT01551888","phase":"PHASE2","title":"Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2012-01","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":24},{"nctId":"NCT00626522","phase":"PHASE2","title":"Aclidinium/Formoterol Fixed Combination Dose Finding Study","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-02","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":808},{"nctId":"NCT01908140","phase":"PHASE3","title":"Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2013-09","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":933}],"_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":["Duaklir™ Genuair®","DUAKLIR™ GENUAIR®"],"phase":"marketed","status":"active","brandName":"Aclidinium bromide/formoterol fumarate combination","genericName":"Aclidinium bromide/formoterol fumarate combination","companyName":"AstraZeneca","companyId":"astrazeneca","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Aclidinium bromide and formoterol fumarate work together as a long-acting anticholinergic and long-acting beta-2 agonist to relax airway smooth muscle and improve airflow in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance treatment.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}