{"id":"fluticasone-salmeterol-hfa","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nervousness"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Muscle cramps"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fluticasone propionate binds to glucocorticoid receptors in the lungs, suppressing inflammatory cytokine production and reducing airway edema and mucus secretion. Salmeterol activates beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and sustained airway opening. Together, they provide both anti-inflammatory and bronchodilator effects for maintenance asthma and COPD control.","oneSentence":"Fluticasone propionate (a corticosteroid) reduces airway inflammation while salmeterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:46:54.443Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT06572228","phase":"PHASE4","title":"Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma","status":"RECRUITING","sponsor":"Regeneron Pharmaceuticals","startDate":"2024-08-26","conditions":"Asthma","enrollment":250},{"nctId":"NCT06040268","phase":"PHASE1, PHASE2","title":"Advair HFA in Healthy and HAPE Predisposed Subjects","status":"RECRUITING","sponsor":"University of Colorado, Denver","startDate":"2023-12-12","conditions":"Altitude Edema","enrollment":60},{"nctId":"NCT00576069","phase":"","title":"Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma","status":"RECRUITING","sponsor":"Gelb, Arthur F., M.D.","startDate":"2007-10-25","conditions":"Asthma","enrollment":60},{"nctId":"NCT00521222","phase":"NA","title":"Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes","status":"COMPLETED","sponsor":"Columbia University","startDate":"2007-06","conditions":"Asthma","enrollment":90},{"nctId":"NCT00250341","phase":"PHASE4","title":"Non-invasive Measures of Distal Lung Disease in Asthmatics","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2005-09-30","conditions":"Asthma","enrollment":34},{"nctId":"NCT02139644","phase":"PHASE3","title":"Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2014-06","conditions":"Asthma","enrollment":787},{"nctId":"NCT02141854","phase":"PHASE3","title":"Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2014-06","conditions":"Asthma","enrollment":882},{"nctId":"NCT02175771","phase":"PHASE3","title":"Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2014-07","conditions":"Persistent Asthma","enrollment":758},{"nctId":"NCT02024204","phase":"NA","title":"Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2014-04-09","conditions":"Lung Diseases, Medication Compliance","enrollment":60},{"nctId":"NCT01388595","phase":"PHASE4","title":"Fluticasone and Salmeterol in Allergic Rhinitis","status":"COMPLETED","sponsor":"University of Dundee","startDate":"2006-11","conditions":"Allergic Rhinitis","enrollment":23},{"nctId":"NCT01194700","phase":"PHASE4","title":"Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers","status":"COMPLETED","sponsor":"Brian J Lipworth","startDate":"2009-11","conditions":"Asthma","enrollment":19},{"nctId":"NCT00829257","phase":"PHASE4","title":"Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma","status":"COMPLETED","sponsor":"University of Dundee","startDate":"2009-01","conditions":"Asthma","enrollment":15},{"nctId":"NCT02045953","phase":"PHASE1","title":"A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-01-29","conditions":"Asthma","enrollment":21},{"nctId":"NCT02113436","phase":"PHASE4","title":"Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-05-01","conditions":"Asthma","enrollment":300},{"nctId":"NCT01772368","phase":"PHASE2","title":"Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2013-01","conditions":"Asthma","enrollment":72},{"nctId":"NCT00441441","phase":"PHASE3","title":"A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-02","conditions":"Asthma","enrollment":351},{"nctId":"NCT00633217","phase":"PHASE4","title":"Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-03","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":247},{"nctId":"NCT00400608","phase":"PHASE4","title":"A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-10","conditions":"Asthma","enrollment":28},{"nctId":"NCT02466347","phase":"PHASE1","title":"Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block","status":"COMPLETED","sponsor":"Intech Biopharm Ltd.","startDate":"2014-06","conditions":"Asthma, Chronic Obstructive Pulmonary Disease (COPD)","enrollment":45},{"nctId":"NCT02466503","phase":"PHASE1","title":"Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block","status":"COMPLETED","sponsor":"Intech Biopharm Ltd.","startDate":"2014-08","conditions":"Asthma, Chronic Obstructive Pulmonary Disease (COPD)","enrollment":45},{"nctId":"NCT00449046","phase":"PHASE3","title":"Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-03","conditions":"Bronchial Asthma","enrollment":40},{"nctId":"NCT01763463","phase":"","title":"WEUSKOP6416: Evaluating Pneumonia in Chronic Obstructive Pulmonary Disease (COPD) Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-07","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1},{"nctId":"NCT01795664","phase":"PHASE3","title":"Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients","status":"COMPLETED","sponsor":"FLUIDDA nv","startDate":"2013-03","conditions":"Asthma","enrollment":16},{"nctId":"NCT00404261","phase":"PHASE4","title":"Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-01","conditions":"Asthma","enrollment":132},{"nctId":"NCT00646009","phase":"PHASE3","title":"Symbicort Onset of Action 2","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-03","conditions":"Asthma","enrollment":48},{"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},{"nctId":"NCT00448435","phase":"PHASE3","title":"Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-04","conditions":"Bronchial Asthma","enrollment":51},{"nctId":"NCT00646620","phase":"PHASE3","title":"Symbicort Onset of Action 1","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-04","conditions":"Asthma","enrollment":48},{"nctId":"NCT00867737","phase":"PHASE4","title":"Onset of Action of Advair Hydrofluoroalkane (HFA) 115/21 in Comparison to Symbicort Pressurised Metered-Dose Inhalers (pMDI) 160/4.5 Measured by Impulse Oscillometry (IOS)","status":"UNKNOWN","sponsor":"Allergy and Asthma Center of El Paso","startDate":"2008-09","conditions":"Asthma","enrollment":30}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"DYSPNOEA"},{"count":1,"reaction":"ANGINA UNSTABLE"},{"count":1,"reaction":"CHEST DISCOMFORT"},{"count":1,"reaction":"CLOSTRIDIUM TEST POSITIVE"},{"count":1,"reaction":"COLITIS"},{"count":1,"reaction":"CROHN^S DISEASE"},{"count":1,"reaction":"CYSTITIS"},{"count":1,"reaction":"CYTOMEGALOVIRUS TEST POSITIVE"},{"count":1,"reaction":"FATIGUE"},{"count":1,"reaction":"HEART RATE INCREASED"}],"_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":"marketed","status":"active","brandName":"Fluticasone/Salmeterol HFA","genericName":"Fluticasone/Salmeterol HFA","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fluticasone propionate (a corticosteroid) reduces airway inflammation while salmeterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}