{"id":"skp-flutiform-hfa-pmdi","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nervousness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fluticasone propionate reduces airway inflammation by binding to glucocorticoid receptors, while formoterol provides bronchodilation through beta-2 adrenergic receptor agonism. The combination addresses both the inflammatory and bronchospastic components of asthma, with the HFA propellant system enabling efficient lung deposition.","oneSentence":"SKP FlutiForm HFA is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) delivered via pressurized metered-dose inhaler for maintenance treatment of asthma.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:59.222Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"}]},"trialDetails":[{"nctId":"NCT00393991","phase":"PHASE3","title":"Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2006-07","conditions":"Asthma","enrollment":475},{"nctId":"NCT00394199","phase":"PHASE3","title":"Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2006-06","conditions":"Asthma","enrollment":357},{"nctId":"NCT00747318","phase":"PHASE3","title":"A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2008-09","conditions":"Asthma","enrollment":280},{"nctId":"NCT00393952","phase":"PHASE3","title":"New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2006-06","conditions":"Asthma","enrollment":557},{"nctId":"NCT00649025","phase":"PHASE3","title":"A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2008-03","conditions":"Asthma","enrollment":438},{"nctId":"NCT00734292","phase":"PHASE2","title":"Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2008-09","conditions":"Mild to Moderate Asthma","enrollment":39},{"nctId":"NCT00657774","phase":"PHASE1","title":"A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands","status":"COMPLETED","sponsor":"SkyePharma AG","startDate":"2008-04","conditions":"Asthma","enrollment":160}],"_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":["FlutiForm","fluticasone propionate/formoterol fumarate"],"phase":"phase_3","status":"active","brandName":"SKP FlutiForm HFA pMDI","genericName":"SKP FlutiForm HFA pMDI","companyName":"SkyePharma AG","companyId":"skyepharma-ag","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SKP FlutiForm HFA is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) delivered via pressurized metered-dose inhaler for maintenance treatment of asthma. Used for Asthma maintenance therapy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}