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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":"2026-03-28T01:05:36.079Z","_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":"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":"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":"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":"NCT00413387","phase":"PHASE3","title":"Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. 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(Symbicort®)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2004-09","conditions":"Bronchial Asthma","enrollment":219},{"nctId":"NCT00394368","phase":"PHASE3","title":"EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2004-11","conditions":"Bronchial Asthma","enrollment":180},{"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":"NCT01803087","phase":"PHASE2","title":"Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2012-02","conditions":"Asthma","enrollment":60},{"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":"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":"NCT00862264","phase":"PHASE3","title":"Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2004-08","conditions":"Asthma","enrollment":286},{"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},{"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 100/6 µg","genericName":"CHF 1535 100/6 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":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}