title: The efficacy of fluticasone furoate administered in the morning or evening is comparable in patients with persistent asthma.
abstract: BACKGROUND
  The inhaled corticosteroid fluticasone furoate (FF) is efficacious as a once-daily treatment for the management of asthma. Asthma is associated with circadian changes, with worsening lung function at night. We compared the efficacy of once-daily FF in the morning or evening for the treatment of asthma.
  
  
  METHODS
  Adults with persistent bronchial asthma were enrolled into this randomised, repeat-dose, double-blind, double-dummy, placebo-controlled, three-way crossover study. After a 14-day run-in period, patients received either: FF 100 μg in the morning (AM); FF 100 μg in the evening (PM); or placebo, via the ELLIPTA(®) dry powder inhaler. Patients received all three treatments (14 ± 2 day duration) separated by a 14- to 21-day washout period. The primary endpoint was 24-h weighted mean forced expiratory volume in 1 s (FEV1) measured at the end of each 14-day treatment.
  
  
  RESULTS
  A total of 28 patients aged between 19 and 67 years were randomised and 21 (75%) completed all three study arms. Once-daily administration of FF 100 μg resulted in an increased 24-hour weighted mean FEV1; differences between the adjusted means for AM and PM FF dosing versus placebo were 0.077 L (90% confidence interval [CI]: 0.001, 0.152) and 0.105 L (90% CI: 0.029, 0.180), respectively (adjusted mean difference: -0.028 L [90% CI: -0.102, 0.045]). AM or PM doses had comparable incidences of adverse events (AEs; 18/23 versus 18/24, respectively), no serious AEs occurred.
  
  
  CONCLUSIONS
  AM and PM doses of once-daily FF 100 μg produced comparable improvements in lung function relative to placebo.
authors.affiliation: GSK R&D Medicines Research Centre, Stevenage, Hertfordshire, UK. Electronic address: Rodger.D.Kempsford@gsk.com.
authors.forename: R D
authors.initials: RD
authors.lastname: Kempsford
authors.affiliation: GSK R&D Stockley Park West, Uxbridge, Middlesex, UK. Electronic address: joanne.x.bal@gsk.com.
authors.forename: J
authors.initials: J
authors.lastname: Bal
authors.affiliation: GSK R&D Medicines Research Centre, Stevenage, Hertfordshire, UK. Electronic address: Amanda.J.Baines@gsk.com.
authors.forename: A
authors.initials: A
authors.lastname: Baines
authors.affiliation: GSK R&D Stockley Park West, Uxbridge, Middlesex, UK. Electronic address: jessica.f.renaux@gsk.com.
authors.forename: J
authors.initials: J
authors.lastname: Renaux
authors.affiliation: GSK Pharmaceuticals Ltd, Bangalore, India. Electronic address: r.2.ramiya@gsk.com.
authors.forename: R
authors.initials: R
authors.lastname: Ravindranath
authors.affiliation: Prince of Wales Hospital Clinical School, University of New South Wales, and Respiratory Medicine, Prince of Wales Hospital, New South Wales, Australia. Electronic address: Paul.Thomas@unsw.edu.au.
authors.forename: P S
authors.initials: PS
authors.lastname: Thomas
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D005938:Glucocorticoids; C523187:fluticasone furoate
keywords: Asthma; Efficacy; Evening dosing; Fluticasone furoate; Inhaled corticosteroid; Morning dosing