{"id":"chf-1535-200-6-g","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nervousness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formulation combines beclomethasone dipropionate (ICS) with formoterol fumarate (LABA). The corticosteroid component suppresses airway inflammation by binding glucocorticoid receptors, while formoterol activates beta-2 adrenergic receptors to produce sustained bronchodilation. This dual mechanism addresses both the inflammatory and obstructive components of chronic respiratory disease.","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":"2026-03-28T01:05:35.081Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"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":"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":"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":"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":"NCT01848769","phase":"PHASE2","title":"Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2009-09","conditions":"Asthma","enrollment":20},{"nctId":"NCT00862394","phase":"PHASE3","title":"A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2009-02","conditions":"Asthma","enrollment":783},{"nctId":"NCT02787967","phase":"PHASE2","title":"Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-08","conditions":"Asthma","enrollment":26},{"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},{"nctId":"NCT02148120","phase":"PHASE2","title":"A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-04","conditions":"Asthma","enrollment":60},{"nctId":"NCT01584492","phase":"PHASE2","title":"Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-12","conditions":"Asthma","enrollment":59}],"_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 200/6 µg","genericName":"CHF 1535 200/6 µg","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}}