{"id":"chf-1535-50-6-g","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nervousness/anxiety"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formulation combines beclomethasone dipropionate (ICS) at 50µg to suppress airway inflammation and formoterol (LABA) at 6µg to provide sustained bronchodilation. This dual mechanism addresses both the inflammatory and obstructive components of chronic respiratory conditions, improving airflow and reducing exacerbations.","oneSentence":"CHF 1535 is a fixed-dose combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and improves bronchodilation in respiratory disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:36.080Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT01468272","phase":"PHASE2","title":"Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-11","conditions":"Asthma in Children","enrollment":26},{"nctId":"NCT01658891","phase":"PHASE3","title":"Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children","status":"WITHDRAWN","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-02","conditions":"Asthma in Children","enrollment":""},{"nctId":"NCT01450774","phase":"PHASE3","title":"Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-09","conditions":"Childhood Asthma","enrollment":72}],"_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":"CHF 1535 50/6µg","genericName":"CHF 1535 50/6µg","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CHF 1535 is a fixed-dose combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and improves bronchodilation in respiratory disease. Used for Asthma maintenance therapy, 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}}