{"id":"chf-1535-pmdi","_chembl":{"chemblId":"CHEMBL6068602","moleculeType":"Protein"},"modality":"Small molecule","_dailymed":null,"_scrapedAt":"2026-03-28T03:26:10.717Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123792,"model":"claude-sonnet-4-5-20250929"},"description":"CHF 1535 pMDI is an investigational pressurized metered-dose inhaler (pMDI) formulation being developed by Chiesi Farmaceutici for respiratory conditions. The compound is currently in Phase 2 clinical development, though specific molecular targets and therapeutic mechanisms have not been publicly disclosed.","indications":{"approved":[{"status":"investigational","condition":"Respiratory disease (specific indication not publicly disclosed)","patientPopulation":"Unknown"}]},"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":"NCT04320342","phase":"PHASE3","title":"A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-04-28","conditions":"COPD, COPD Exacerbation","enrollment":3433},{"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":"NCT05018598","phase":"PHASE4","title":"Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-02-25","conditions":"Asthma","enrollment":320},{"nctId":"NCT02000609","phase":"PHASE2","title":"A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of \"Nexthaler\" Dry Powder Inhaler in COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2013-12","conditions":"COPD","enrollment":49},{"nctId":"NCT01917331","phase":"PHASE3","title":"Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-03","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1368},{"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":"NCT03590379","phase":"PHASE2","title":"Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2018-06-15","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":366},{"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":"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":"NCT00413387","phase":"PHASE3","title":"Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (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":"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":"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":"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":"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":"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},{"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":1,"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":"CHF 1535 pMDI","genericName":"CHF 1535 pMDI","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","firstApprovalDate":"","aiSummary":"CHF 1535 is a small molecule administered via a pressurized metered dose inhaler (pMDI) for the treatment of asthma and bronchial asthma. It contains a combination of budesonide (BDP) and formoterol (FF), which are used to manage symptoms of moderate to severe asthma.","enrichmentLevel":2,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}