title: Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma.
abstract: Fluticasone furoate is a once-daily inhaled corticosteroid. This report provides an overview of safety and efficacy data that support the use of once-daily fluticasone furoate 100 μg or 200 μg in adult and adolescent asthma patients.
  
  
  
  Fourteen clinical studies (six Phase II and eight Phase III) were conducted as part of the fluticasone furoate global clinical development programme in asthma. Safety data from 10 parallel-group, randomised, double-blind Phase II and III studies (including 3345 patients who received at least one dose of fluticasone furoate) were integrated to provide information on adverse events, withdrawals, laboratory assessments, vital signs and hypothalamic-pituitary-adrenal axis function. The efficacy of once-daily fluticasone furoate was evaluated in all included studies.
  
  
  
  Once-daily fluticasone furoate 100 μg and 200 μg safety profiles were consistent with those reported for other inhaled corticosteroids, and both doses consistently demonstrated efficacy versus placebo. In the integrated analysis, no dose-response relationship was observed for the overall incidence of adverse events and there were no significant effects of fluticasone furoate on hypothalamic-pituitary-adrenal axis function.
  
  
  
  Once-daily fluticasone furoate 100 μg and 200 μg had acceptable safety profiles and was efficacious in adult and adolescent patients with asthma. There was no evidence of cortisol suppression at studied doses.
  
  
  
  GSK (NCT01499446/FFA20001, NCT00398645/FFA106783, NCT00766090/112202, NCT00603746/FFA109684, NCT00603278/FFA109685, NCT00603382/FFA109687, NCT01436071/115283, NCT01436110/115285, NCT01159912/112059, NCT01431950/114496, NCT01165138/HZA106827, NCT01086384/106837, NCT01134042/HZA106829 and NCT01244984/1139879).
authors.affiliation: Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada. obyrnep@mcmaster.ca.|Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, 1280 Main Street West, Room 3W10, Hamilton, ON, L8S 4K1, Canada. obyrnep@mcmaster.ca.
authors.forename: Paul M
authors.initials: PM
authors.lastname: O'Byrne
authors.affiliation: Respiratory Medicine Development Centre, GSK, London, TW8 9GS, UK.
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.affiliation: Quantitative Sciences Division, GSK, London, TW8 9GS, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Goldfrad
authors.affiliation: Respiratory Franchise Medical, GSK, London, TW8 9GS, UK.
authors.forename: Namhee
authors.initials: N
authors.lastname: Kwon
authors.affiliation: Global Clinical Safety and Pharmacovigilance, GSK, TW8 9GS, London, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Perrio
authors.affiliation: Respiratory Franchise Medical, GSK, London, TW8 9GS, UK.
authors.forename: Louisa J
authors.initials: LJ
authors.lastname: Yates
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
mesh_terms: D000280:Administration, Inhalation; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D004334:Drug Administration Schedule; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D005938:Glucocorticoids; C523187:fluticasone furoate
keywords: Adverse events; Cortisol suppression; Fluticasone furoate; Forced expiratory volume in one second; Inhaled corticosteroid; Integrated analysis; Safety