{"id":"beclomethasone-dipropionate-formoterol-fumarate","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Hoarseness"},{"rate":null,"effect":"Nervousness/anxiety"}]},"_chembl":{"chemblId":"CHEMBL3989798","moleculeType":"Small molecule","molecularWeight":"840.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a combination inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA). Beclomethasone dipropionate suppresses inflammatory cytokines and immune cell recruitment in the airways. Formoterol fumarate activates beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and improved airflow. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.","oneSentence":"Beclomethasone dipropionate reduces airway inflammation via glucocorticoid receptor activation, while formoterol fumarate bronchodilates by stimulating beta-2 adrenergic receptors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:03:53.568Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT04886999","phase":"PHASE3","title":"Study in Adult Patients With Moderate to Severe Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2022-02-24","conditions":"Asthma","enrollment":78},{"nctId":"NCT07489911","phase":"","title":"Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)","status":"RECRUITING","sponsor":"Chiesi Slovenija, d.o.o.","startDate":"2024-11-04","conditions":"Asthma, Asthma Patients, Asthma Bronchiale","enrollment":200},{"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":"NCT05888350","phase":"NA","title":"Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","startDate":"2023-04-01","conditions":"Cough","enrollment":502},{"nctId":"NCT07282886","phase":"PHASE2","title":"VENTURI (VENTilation Using Respiratory Imaging)","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-03-15","conditions":"Asthma","enrollment":20},{"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":"NCT06429475","phase":"PHASE3","title":"Anti-Inflammatory Reliever South Africa","status":"RECRUITING","sponsor":"University of KwaZulu","startDate":"2024-06-06","conditions":"Asthma","enrollment":1038},{"nctId":"NCT07301736","phase":"PHASE2","title":"Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma","status":"RECRUITING","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2025-12-17","conditions":"Asthma","enrollment":780},{"nctId":"NCT07232264","phase":"NA","title":"Respiratory and Peripheral Muscle Strength as Predictors of Inhaler Treatment Response in Asthma: A Comparison of DPI and MDI Devices","status":"COMPLETED","sponsor":"Bugra Kerget","startDate":"2025-03-01","conditions":"Asthma (Diagnosis)","enrollment":80},{"nctId":"NCT07052942","phase":"PHASE4","title":"Individualizing Treatment for Asthma in Primary Care (Full Study)","status":"RECRUITING","sponsor":"DARTNet Institute","startDate":"2025-08-01","conditions":"Asthma, Asthma Attack, Asthma Exacerbations","enrollment":3200},{"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":"NCT06100042","phase":"","title":"Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chiesi Italia","startDate":"2024-04-24","conditions":"Asthma","enrollment":200},{"nctId":"NCT06272370","phase":"PHASE4","title":"Individualizing Treatment for Asthma in Primary Care","status":"COMPLETED","sponsor":"DARTNet Institute","startDate":"2024-02-01","conditions":"Asthma, Bronchial Diseases, Respiratory Tract Infections","enrollment":103},{"nctId":"NCT04937543","phase":"PHASE2","title":"Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19","status":"COMPLETED","sponsor":"UPECLIN HC FM Botucatu Unesp","startDate":"2021-06-28","conditions":"Covid19","enrollment":50},{"nctId":"NCT06869382","phase":"PHASE4","title":"ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression","status":"COMPLETED","sponsor":"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation","startDate":"2023-01-01","conditions":"Asthma Patients","enrollment":26},{"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":"NCT00476268","phase":"PHASE3","title":"Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2004-02","conditions":"Asthma","enrollment":824},{"nctId":"NCT06657066","phase":"PHASE2, PHASE3","title":"EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA","status":"COMPLETED","sponsor":"King Edward Medical University","startDate":"2021-12-06","conditions":"Asthma Patients","enrollment":74},{"nctId":"NCT05830071","phase":"PHASE1","title":"A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-03-29","conditions":"Asthma, Chronic Obstructive Pulmonary Disease (COPD)","enrollment":95},{"nctId":"NCT06571942","phase":"PHASE4","title":"Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure","status":"RECRUITING","sponsor":"National Institute of Respiratory Diseases, Mexico","startDate":"2023-11-15","conditions":"COPD Bronchitis, Pollution Related Respiratory Disorder","enrollment":128},{"nctId":"NCT06567977","phase":"","title":"TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients","status":"RECRUITING","sponsor":"Chiesi Poland Sp. z o.o.","startDate":"2024-08","conditions":"Asthma","enrollment":60},{"nctId":"NCT02062463","phase":"PHASE3","title":"Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2014-05-28","conditions":"Asthma","enrollment":485},{"nctId":"NCT05948891","phase":"","title":"Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study","status":"RECRUITING","sponsor":"Chiesi SAS","startDate":"2023-08-01","conditions":"COPD","enrollment":500},{"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":"NCT05728749","phase":"","title":"A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes","status":"UNKNOWN","sponsor":"Chiesi SAS","startDate":"2023-03-03","conditions":"ASTHMA","enrollment":300},{"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":"NCT03846570","phase":"PHASE3","title":"Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial","status":"TERMINATED","sponsor":"Erasmus Medical Center","startDate":"2019-01-29","conditions":"Bronchiectasis","enrollment":34},{"nctId":"NCT03662711","phase":"PHASE4","title":"Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease","status":"TERMINATED","sponsor":"Università degli Studi di Ferrara","startDate":"2018-11-11","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":843},{"nctId":"NCT03795350","phase":"PHASE1","title":"Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2019-01-14","conditions":"Chronic Obstructive Pulmonary Disease, Asthma","enrollment":19},{"nctId":"NCT01615874","phase":"PHASE2","title":"Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)","status":"WITHDRAWN","sponsor":"Organon and Co","startDate":"2013-01","conditions":"Asthma","enrollment":""},{"nctId":"NCT04671355","phase":"PHASE4","title":"TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD","status":"WITHDRAWN","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-10-04","conditions":"COPD","enrollment":""},{"nctId":"NCT04876677","phase":"PHASE3","title":"Functional Respiratory Imaging Study","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-05-25","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":25},{"nctId":"NCT03627858","phase":"","title":"Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting","status":"COMPLETED","sponsor":"Chiesi SA/NV","startDate":"2018-08-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":149},{"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":"NCT02119234","phase":"PHASE1","title":"Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-03","conditions":"COPD","enrollment":36},{"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":"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":"NCT02040597","phase":"PHASE1","title":"A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-01","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":42},{"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":"NCT01476813","phase":"PHASE2","title":"Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2012-03","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":281},{"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":"NCT04179461","phase":"PHASE2","title":"Personalized Treatment Algorithms for Difficult-to-treat Asthma","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2018-03-16","conditions":"Asthma in Children","enrollment":21},{"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":"NCT04737655","phase":"PHASE4","title":"Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care","status":"UNKNOWN","sponsor":"PARZIBUT Gilles","startDate":"2021-02-15","conditions":"COPD Exacerbation","enrollment":200},{"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":"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":"NCT04421742","phase":"","title":"The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and SAD in COPD Patients.","status":"COMPLETED","sponsor":"Alfredo Antonio Chetta","startDate":"2017-05-31","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":43},{"nctId":"NCT03268226","phase":"PHASE3","title":"Functional Respiratory Imaging Study (FRI)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2017-11-20","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":20},{"nctId":"NCT02048644","phase":"PHASE2","title":"Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary Fibrosis","status":"COMPLETED","sponsor":"Hull University Teaching Hospitals NHS Trust","startDate":"2014-03","conditions":"Idiopathic Pulmonary Fibrosis","enrollment":20},{"nctId":"NCT01656005","phase":"PHASE4","title":"Beta Blocker Therapy in Moderate to Severe COPD","status":"COMPLETED","sponsor":"University of Dundee","startDate":"2012-08","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":18},{"nctId":"NCT03108534","phase":"PHASE2","title":"A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2017-02-28","conditions":"Asthma","enrollment":65},{"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":"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":"NCT02975843","phase":"PHASE1","title":"Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-11-21","conditions":"Chronic Obstructive Pulmonary Disease, Asthma","enrollment":28},{"nctId":"NCT01351792","phase":"PHASE3","title":"A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-09","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":113},{"nctId":"NCT01245569","phase":"PHASE3","title":"A Study in Patients With Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2011-04","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":373},{"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":"NCT01570478","phase":"PHASE3","title":"A Study in Patients With Asthma","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2012-07","conditions":"Asthma","enrollment":108},{"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":"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":"NCT02790047","phase":"NA","title":"Effect of Home-base Exercise With Conical-PEP Device on Physical Performance and Quality of Life in COPD","status":"UNKNOWN","sponsor":"Khon Kaen University","startDate":"2016-10","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":50},{"nctId":"NCT02526758","phase":"PHASE4","title":"Small Airways Evaluation and Treatment","status":"UNKNOWN","sponsor":"Zhujiang Hospital","startDate":"2015-04","conditions":"Pulmonary Disease，Chronic Obstructive;","enrollment":90},{"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},{"nctId":"NCT02345993","phase":"PHASE4","title":"Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis","status":"UNKNOWN","sponsor":"National Institute of Respiratory Diseases, Mexico","startDate":"2015-01","conditions":"Asthma, Asthmatic Crisis","enrollment":120},{"nctId":"NCT01453881","phase":"PHASE3","title":"Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation","status":"COMPLETED","sponsor":"Universidade Federal de Pernambuco","startDate":"2011-04","conditions":"Asthma","enrollment":45},{"nctId":"NCT01620099","phase":"PHASE4","title":"Small Airways Involvement in Smoker Asthmatic Patients: a Pilot Study","status":"COMPLETED","sponsor":"Università degli Studi di Ferrara","startDate":"2011-11","conditions":"Asthma","enrollment":60},{"nctId":"NCT01839851","phase":"","title":"Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids","status":"UNKNOWN","sponsor":"Meir Medical Center","startDate":"2013-05","conditions":"ASTHMA, ALLERGIC RHINITIS","enrollment":60},{"nctId":"NCT01466712","phase":"PHASE4","title":"Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function","status":"UNKNOWN","sponsor":"KU Leuven","startDate":"2011-11","conditions":"COPD, Emphysema, Small Airway Disease","enrollment":20},{"nctId":"NCT00910793","phase":"PHASE4","title":"Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients","status":"COMPLETED","sponsor":"Wilfried De Backer","startDate":"2008-08","conditions":"Asthma","enrollment":29},{"nctId":"NCT01204034","phase":"PHASE3","title":"Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"University Hospital, Antwerp","startDate":"2010-09","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":29},{"nctId":"NCT01242098","phase":"","title":"Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management","status":"COMPLETED","sponsor":"Research in Real-Life Ltd","startDate":"2008-01","conditions":"Asthma","enrollment":137},{"nctId":"NCT01327001","phase":"","title":"Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-04","conditions":"Asthma","enrollment":2815},{"nctId":"NCT01255579","phase":"PHASE4","title":"Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma","status":"COMPLETED","sponsor":"Università degli Studi di Brescia","startDate":"2007-07","conditions":"Bronchial Asthma","enrollment":10}],"_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":["Foster NEXThaler®","BDP/FF"],"phase":"phase_3","status":"active","brandName":"Beclomethasone Dipropionate/Formoterol Fumarate","genericName":"Beclomethasone Dipropionate/Formoterol Fumarate","companyName":"Alfredo Antonio Chetta","companyId":"alfredo-antonio-chetta","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Beclomethasone dipropionate reduces airway inflammation via glucocorticoid receptor activation, while formoterol fumarate bronchodilates by stimulating beta-2 adrenergic receptors. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}