{"id":"chf1535-next-dpi","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Cough"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"CHF1535 NEXT DPI is a triple-component fixed-dose combination delivered via dry powder inhaler that combines an inhaled corticosteroid (ICS) with dual bronchodilators—a long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA). This combination provides anti-inflammatory and bronchodilatory effects to improve airflow and reduce exacerbations in COPD patients.","oneSentence":"CHF1535 is a dual bronchodilator combining an inhaled corticosteroid with a long-acting beta-2 agonist and long-acting muscarinic antagonist for maintenance treatment of chronic obstructive pulmonary disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:26:25.620Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD) maintenance treatment"}]},"trialDetails":[{"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":"NCT01349257","phase":"PHASE2","title":"Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-05","conditions":"Asthma","enrollment":24},{"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":"NCT01191424","phase":"PHASE2","title":"A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2010-10","conditions":"Asthma","enrollment":57},{"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":"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":"NCT00868023","phase":"PHASE2","title":"Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2009-02","conditions":"Asthma","enrollment":69}],"_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_2","status":"active","brandName":"CHF1535 NEXT DPI","genericName":"CHF1535 NEXT DPI","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CHF1535 is a dual bronchodilator combining an inhaled corticosteroid with a long-acting beta-2 agonist and long-acting muscarinic antagonist for maintenance treatment of 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}}