{"id":"beclomethasone-plus-formoterol-fixed-combination","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nervousness/anxiety"}]},"_chembl":{"chemblId":"CHEMBL1586","moleculeType":"Small molecule","molecularWeight":"408.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Beclomethasone acts as a glucocorticoid receptor agonist that suppresses inflammatory cytokine production and immune cell recruitment in the airways. Formoterol is a beta-2 adrenergic receptor agonist that increases intracellular cAMP, causing bronchial smooth muscle relaxation and bronchodilation. Together, this combination addresses both the inflammatory and obstructive components of asthma and COPD.","oneSentence":"Beclomethasone (a corticosteroid) reduces airway inflammation while formoterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:03:48.706Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD)"}]},"trialDetails":[{"nctId":"NCT06786767","phase":"","title":"Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting","status":"COMPLETED","sponsor":"Chiesi Bulgaria","startDate":"2025-02-01","conditions":"Asthma, Asthma Patients, Asthma Bronchiale","enrollment":281},{"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":"NCT03963167","phase":"","title":"Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)","status":"COMPLETED","sponsor":"Chiesi Italia","startDate":"2019-08-21","conditions":"COPD","enrollment":661},{"nctId":"NCT05168995","phase":"","title":"Effects of Beclometasone Dipropionate/Formoterol Fumarate Via NEXT(Haler) in a Real-world Study on Asthma Control","status":"COMPLETED","sponsor":"Chiesi Italia","startDate":"2022-04-12","conditions":"Asthma","enrollment":620},{"nctId":"NCT07406048","phase":"","title":"Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients","status":"NOT_YET_RECRUITING","sponsor":"Chiesi Farmaceutica Ltda.","startDate":"2026-01-30","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":396},{"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":"NCT04480242","phase":"","title":"Asthma Research in Children and Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Parc de Salut Mar","startDate":"2017-07-26","conditions":"Persistent Asthma, Asthma in Children, Asthma Exacerbation","enrollment":525},{"nctId":"NCT07058259","phase":"NA","title":"Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD","status":"ACTIVE_NOT_RECRUITING","sponsor":"Istanbul Medeniyet University","startDate":"2024-11-15","conditions":"COPD (Chronic Obstructive Pulmonary Disease), Acupuncture","enrollment":60},{"nctId":"NCT06234345","phase":"PHASE3","title":"Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)","status":"NOT_YET_RECRUITING","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-09","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1252},{"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":"NCT06678191","phase":"","title":"Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting","status":"RECRUITING","sponsor":"Chiesi Hungary Ltd.","startDate":"2024-10-24","conditions":"Asthma, Chronic Obstructive Pulmonary Disease (COPD), Asthma Bronchiale","enrollment":800},{"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":"NCT05898984","phase":"PHASE1","title":"Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-04-24","conditions":"Asthma","enrollment":69},{"nctId":"NCT03453112","phase":"PHASE3","title":"Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2017-10-09","conditions":"Asthma","enrollment":494},{"nctId":"NCT05097014","phase":"PHASE4","title":"CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-10-28","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":106},{"nctId":"NCT03290287","phase":"","title":"Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2017-03-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":26839},{"nctId":"NCT00929851","phase":"PHASE3","title":"BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2009-10","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1199},{"nctId":"NCT02467452","phase":"PHASE3","title":"Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2015-05","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1479},{"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":"NCT01911364","phase":"PHASE3","title":"Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":3686},{"nctId":"NCT01738087","phase":"PHASE2","title":"Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2012-11","conditions":"Asthmatic","enrollment":30},{"nctId":"NCT00476099","phase":"PHASE3","title":"Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2006-12","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":828},{"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":"NCT02127866","phase":"PHASE2","title":"Triple in Asthma Dose Finding","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-04","conditions":"Asthma","enrollment":211},{"nctId":"NCT03197818","phase":"PHASE3","title":"Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-12-14","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":990},{"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":"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":"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":"NCT01658891","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":"WITHDRAWN","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-02","conditions":"Asthma in Children","enrollment":""},{"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":"NCT03333018","phase":"","title":"A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-07-06","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":22155},{"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":"NCT00901368","phase":"PHASE4","title":"FACTO Study (Foster® As Complete Treatment Option)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2009-05","conditions":"Asthmatic Patients","enrollment":431},{"nctId":"NCT00861926","phase":"PHASE3","title":"Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2009-03","conditions":"Asthma","enrollment":2079},{"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":"NCT00497237","phase":"PHASE3","title":"Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2007-04","conditions":"Asthma","enrollment":382},{"nctId":"NCT01475032","phase":"PHASE3","title":"Efficacy Study of the Product \"CHF 1535\" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-09","conditions":"Asthma","enrollment":638},{"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},{"nctId":"NCT01650441","phase":"PHASE2","title":"Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients","status":"COMPLETED","sponsor":"University Hospital, Antwerp","startDate":"2012-04","conditions":"Asthma","enrollment":31}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":13,"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":"Beclomethasone plus formoterol fixed combination","genericName":"Beclomethasone plus formoterol fixed combination","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Beclomethasone (a corticosteroid) reduces airway inflammation while formoterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}