{"id":"fluticasone-propionate-hydrofluoroalkane-hfa","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Throat irritation","drugRate":"10%","severity":"Mild"},{"effect":"Oral candidiasis","drugRate":"5%","severity":"Mild to Moderate"},{"effect":"Hoarseness","drugRate":"3%","severity":"Mild"},{"effect":"Headache","drugRate":"2%","severity":"Mild"}],"contraindications":["Hypersensitivity to fluticasone propionate or any component of the formulation"],"specialPopulations":{"Geriatric":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Lactation":"It is not known whether fluticasone propionate is excreted in human milk. Caution should be exercised when administered to a nursing woman.","Pediatric":"Safety and effectiveness in pediatric patients under 4 years of age have not been established.","Pregnancy":"Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."}},"trials":[],"_chembl":null,"aliases":["Flovent HFA"],"patents":[{"title":"Pharmaceutical compositions containing fluticasone propionate","number":"US6228898B1","issueDate":"2001-05-08","expirationDate":"2021-05-08"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2000-01-01","type":"Approval","milestone":"First approval for asthma","regulator":"FDA"},{"date":"2005-01-01","type":"Approval","milestone":"Approval for COPD","regulator":"FDA"}],"_dailymed":null,"aiSummary":"Fluticasone propionate HFA is an inhaled corticosteroid developed by Organon and Co for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by reducing inflammation in the airways, thereby preventing symptoms such as wheezing and shortness of breath. Despite its effectiveness, it does not have an FDA label, which may limit its use in certain clinical settings. The drug has a well-established safety profile but includes common side effects like throat irritation and oral candidiasis. It competes in a crowded market of inhaled corticosteroids and combination therapies.","ecosystem":[],"mechanism":{"target":"Glucocorticoid receptors","novelty":"Fluticasone propionate HFA uses a hydrofluoroalkane (HFA) propellant, which is environmentally friendly and more stable compared to older chlorofluorocarbon (CFC) propellants.","modality":"Inhalation","drugClass":"Inhaled corticosteroid","explanation":"It exerts its anti-inflammatory effects by inhibiting the production of inflammatory cytokines and chemokines, reducing the recruitment and activation of immune cells in the airways.","oneSentence":"Fluticasone propionate HFA is a potent inhaled corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors.","technicalDetail":"The drug binds to intracellular glucocorticoid receptors, which then translocate to the nucleus and modulate gene expression, leading to the downregulation of pro-inflammatory genes and upregulation of anti-inflammatory genes."},"_scrapedAt":"2026-03-27T23:46:48.734Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"Not available","annualCostUS":"$200 - $300","currentRevenue":"Not available","patientPopulation":"Asthma and COPD patients","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Budesonide (Pulmicort)","Mometasone furoate (Asmanex)","Beclomethasone dipropionate (Qvar)"],"indications":{"approved":["Asthma","Chronic Obstructive Pulmonary Disease (COPD)"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"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":"NCT01396278","phase":"PHASE2","title":"Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat 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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":"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":"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":"NCT01576718","phase":"PHASE2","title":"A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2012-04","conditions":"Asthma","enrollment":889},{"nctId":"NCT00370097","phase":"PHASE1","title":"FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-08-30","conditions":"Asthma","enrollment":16},{"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":"NCT01479621","phase":"PHASE2","title":"A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2012-01","conditions":"Asthma","enrollment":909},{"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":"NCT01184118","phase":"NA","title":"DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2009-03","conditions":"Lung Disease","enrollment":36},{"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":"NCT01287351","phase":"","title":"Real-world Effectiveness and Cost-effectiveness of Qvar Versus FP, a US Study","status":"COMPLETED","sponsor":"Research in Real-Life Ltd","startDate":"2004-01","conditions":"Asthma","enrollment":82903},{"nctId":"NCT01141439","phase":"","title":"Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management","status":"COMPLETED","sponsor":"Research in Real-Life Ltd","startDate":"2001-01","conditions":"Asthma","enrollment":815377},{"nctId":"NCT01729351","phase":"","title":"Qvar Therapy in Smoking Asthmatics","status":"COMPLETED","sponsor":"Research in Real-Life Ltd","startDate":"2011-11","conditions":"Asthma, Smoking","enrollment":7195},{"nctId":"NCT00307970","phase":"PHASE4","title":"Impact of Anti-static Chamber/Mask","status":"COMPLETED","sponsor":"University of Florida","startDate":"2003-04","conditions":"Asthma","enrollment":12},{"nctId":"NCT00308932","phase":"PHASE4","title":"Effect of Age and Device on Delivery of Fluticasone","status":"COMPLETED","sponsor":"University of 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AG","startDate":"2006-06","conditions":"Asthma","enrollment":557},{"nctId":"NCT01141452","phase":"","title":"Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD","status":"COMPLETED","sponsor":"Research in Real-Life Ltd","startDate":"2001-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":815377},{"nctId":"NCT00394121","phase":"PHASE3","title":"New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2006-03","conditions":"Asthma","enrollment":400},{"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":[],"genericFilers":["Teva Pharmaceuticals","Mylan Pharmaceuticals","Sandoz Inc."],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":42,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"fluticasone propionate hydrofluoroalkane (HFA)","genericName":"fluticasone propionate hydrofluoroalkane (HFA)","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"Not available","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}