title: Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial.
abstract: BACKGROUND
  Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.
  
  
  METHODS
  This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study.
  
  
  RESULTS
  There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).
  
  
  CONCLUSIONS
  FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated.
  
  
  BACKGROUND
  www.clinicaltrials.gov, registration number: NCT01436071.
authors.affiliation: Michael G DeGroote School of Medicine, Hamilton, ON, Canada. obyrnep@mcmaster.ca.
authors.forename: Paul M
authors.initials: PM
authors.lastname: O'Byrne
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.forename: Jan
authors.initials: J
authors.lastname: Lötvall
authors.forename: Richard
authors.initials: R
authors.lastname: Forth
authors.forename: Hilary
authors.initials: H
authors.lastname: Medley
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects*; D001249:Asthma / Q000175:diagnosis* / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; C523187:fluticasone furoate
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