Efficacy and Safety Study in Subjects With Asthma

Summary

The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

Timeline

Start

2009-09

Primary completion

2010-01

Completion

2010-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs GW642444 6.25 µg QD; p <0.001; Mean Difference (Final Values) 0.094 (95% CI 0.049 to 0.140) NCT00980200 ↗

Publications

• Background Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta(2) agonist, vilanterol, in persistent asthma: a randomised trial. Respir Med. 2012 Aug;106(8):1110-5. doi: 10.1016/j.rmed.2012.03.007. Epub 2012 Apr 19.

Drugs

Indications