title: Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial.
abstract: BACKGROUND
  Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma.
  
  
  METHODS
  Asthma patients maintained on ICS for ≥ 3 months with baseline morning forced expiratory volume in one second (FEV(1)) 50-80% of predicted normal value and FEV(1) reversibility of ≥ 12% and ≥ 200 ml were eligible. The primary endpoint was mean change from baseline FEV(1) at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV(1).
  
  
  RESULTS
  A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV(1) compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV(1) at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV(1) than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups.
  
  
  CONCLUSIONS
  FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma.
  
  
  BACKGROUND
  NCT00398645.
authors: School of Translational Medicine, Manchester Academic Health Science Centre, University of Manchester, UK. ashley.woodcock@manchester.ac.uk
authors: Ashley
authors: A
authors: Woodcock
authors: Eric D
authors: ED
authors: Bateman
authors: William W
authors: WW
authors: Busse
authors: Jan
authors: J
authors: Lötvall
authors: Neil G
authors: NG
authors: Snowise
authors: Richard
authors: R
authors: Forth
authors: Loretta
authors: L
authors: Jacques
authors: Brett
authors: B
authors: Haumann
authors: Eugene R
authors: ER
authors: Bleecker
mesh_terms: D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D001991:Bronchitis / Q000139:chemically induced; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; C523187:fluticasone furoate