{"id":"chf-1535","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Nasopharyngitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug works through two complementary pathways: the beta-2 agonist component stimulates beta-2 adrenergic receptors to relax airway smooth muscle, while the muscarinic antagonist blocks M3 receptors to prevent acetylcholine-induced bronchoconstriction. This dual mechanism provides synergistic bronchodilation and improved lung function in COPD patients.","oneSentence":"CHF 1535 is a dual bronchodilator that combines a long-acting beta-2 agonist with a long-acting muscarinic antagonist to improve airway function in chronic obstructive pulmonary disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:36.080Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT01577082","phase":"PHASE3","title":"Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2012-04-20","conditions":"Asthma","enrollment":542},{"nctId":"NCT04320342","phase":"PHASE3","title":"A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-04-28","conditions":"COPD, COPD Exacerbation","enrollment":3433},{"nctId":"NCT05292586","phase":"PHASE3","title":"A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-08-31","conditions":"Asthma","enrollment":1377},{"nctId":"NCT03888131","phase":"PHASE3","title":"Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2018-07-30","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":750},{"nctId":"NCT05018598","phase":"PHASE4","title":"Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-02-25","conditions":"Asthma","enrollment":320},{"nctId":"NCT02000609","phase":"PHASE2","title":"A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of \"Nexthaler\" Dry Powder Inhaler in COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2013-12","conditions":"COPD","enrollment":49},{"nctId":"NCT01917331","phase":"PHASE3","title":"Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-03","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1368},{"nctId":"NCT01343745","phase":"PHASE2","title":"Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2008-02","conditions":"Mild Persistent Asthma","enrollment":18},{"nctId":"NCT01176747","phase":"PHASE1, PHASE2","title":"Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2010-08","conditions":"Pulmonary Disease, Chronic Obstructive, Asthma","enrollment":28},{"nctId":"NCT01738087","phase":"PHASE2","title":"Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2012-11","conditions":"Asthmatic","enrollment":30},{"nctId":"NCT03590379","phase":"PHASE2","title":"Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2018-06-15","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":366},{"nctId":"NCT02676076","phase":"PHASE3","title":"TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-02-17","conditions":"Asthma","enrollment":1153},{"nctId":"NCT02676089","phase":"PHASE3","title":"TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-04-06","conditions":"Asthma","enrollment":1433},{"nctId":"NCT00413387","phase":"PHASE3","title":"Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. 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Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}