title: Efficacy and safety of once-daily GW870086 a novel selective glucocorticoid in mild-moderate asthmatics: a randomised, two-way crossover, controlled clinical trial.
abstract: OBJECTIVE
  To assess the efficacy of inhaled, repeat doses (28 days) of the glucocorticoid agonist GW870086, which has been designed to inhibit gene transrepression of the glucocorticoid receptor while preserving its transactivation.
  
  
  METHODS
  This was a randomised, placebo-controlled, two-way crossover study, approved by the independent ethics committees of the study centres. Subjects with FEV(1) 40-85% of the predicted normal value (n = 36) received GW870086 (1 mg, once-daily) and placebo.
  
  
  RESULTS
  No significant change from baseline in forced expiratory volume in one second (FEV(1)) was seen following administration of GW8780086 1 mg relative to placebo; mean FEV(1) (day 28), relative to placebo, was (95% confidence intervals [CI]) -0.077 L (-0.192, 0.038). A moderate positive placebo response was observed on Days 14 and 28: Mean FEV(1) (95% CI) was 0.115 L (0.040, 0.189) and 0.115 L (0.019, 0.212), respectively. The placebo response was more notable in treatment period 1 and was larger than the response to GW870086 1 mg on day 28, irrespective of period. Peak expiratory flow rate results were consistent with FEV(1) and no difference was seen between the GW870086 and placebo for rescue medication usage.
  
  
  CONCLUSIONS
  This total lack of effect suggests that repeat-dose GW8700861 mg has suboptimal efficacy in mild to moderate asthma.
authors.affiliation: GlaxoSmithKline, Gunnels Wood Road, Stevenage , Hertfordshire , UK .
authors.forename: Philippe
authors.initials: P
authors.lastname: Bareille
authors.forename: Kelly
authors.initials: K
authors.lastname: Hardes
authors.forename: Alison C
authors.initials: AC
authors.lastname: Donald
mesh_terms: D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D013256:Steroids / Q000008:administration & dosage* / Q000009:adverse effects; D017211:Treatment Failure; D055815:Young Adult
chemical_list: C581038:GW870086X; D013256:Steroids