{"id":"chf-1535-100-6-pmdi-2-months","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nervousness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formulation combines an inhaled corticosteroid (ICS) component that suppresses airway inflammation and a long-acting beta-2 agonist (LABA) that provides sustained bronchodilation. Delivered via pressurized metered-dose inhaler (pMDI), this combination therapy addresses both 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":"2026-03-28T00:44:56.014Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT01345916","phase":"PHASE3","title":"Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-03","conditions":"Asthma","enrollment":932}],"_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":["Foster®"],"phase":"phase_3","status":"active","brandName":"CHF 1535 100/6 pMDI 2 months","genericName":"CHF 1535 100/6 pMDI 2 months","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}}