Efficacy and safety of once-daily GW870086 a novel selective glucocorticoid in mild-moderate asthmatics: a randomised, two-way crossover, controlled clinical trial.

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 FEV1 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 (FEV1) was seen following administration of GW8780086 1mg relative to placebo; mean FEV1 (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 FEV1 (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 1mg on day 28, irrespective of period. Peak expiratory flow rate results were consistent with FEV1 and no difference was seen between the GW870086 and placebo for rescue medication usage. Conclusion: This total lack of effect suggests that repeat-dose GW8700861 mg has suboptimal efficacy in mild to moderate asthma.