Efficacy of a New Selective Steroid (GW870086) in Asthma: An Adaptive, Randomised, Controlled Trial

Objective: To assess the efficacy of inhaled, repeat doses (28 days) of the glucocorticoid agonist GW870086. Methods: This was a randomised, placebo-controlled, parallel group study in subjects with persistent asthma (n=135) who received GW870086 (2, 3, or 4 mg, once-daily) or placebo. Results: Improvements in forced expiratory volume in one second (FEV1) were seen following all three doses of GW870086 relative to placebo. Mean improvements (95% confidence interval) of: 0.172 L (0.015, 0.329), 0.105 L (-0.053, 0.263) and 0.159 L (0.001, 0.316) were observed for 2 mg, 3 mg and 4 mg, respectively, at Day 28. Peak expiratory flow rate results were consistent with FEV1 and rescue medication was administered more frequently in the placebo group than all three GW870086 treatment arms. Conclusion: This study provided a positive outcome with all doses of GW870086 demonstrating improvements in lung function compared with placebo.