Randomised, double-blind, placebo-controlled crossover study to investigate different dosing regimens of olodaterol delivered via Respimat® in patients with moderate to severe persistent asthma.

ABSTRACT: A Phase II, multicentre, randomised, double-blind, placebo-controlled, crossover trial comparing the 24-h forced expiratory volume in 1 s (FEV1) time profile after 3 weeks' treatment with once-daily (QD) or twice-daily (BID) olodaterol (at the same total daily dose) versus placebo delivered via Respimat® in patients with moderate to severe asthma.Patients were randomised to different sequences of olodaterol with 2-week washout, either as a total daily dose of 5 ?g (5 ?g QD [AM] or 2.5 ?g BID) or placebo, or 10 ?g (10 ?g QD [AM] or 5 ?g BID) or placebo. Primary end point was FEV1 area under the curve from 0 to 24 h (AUC0-24) response (defined as change from study baseline FEV1) after 3 weeks. Key secondary end points were FEV1 AUC0-12 and AUC12-24 responses.Two hundred and six patients received treatment. All olodaterol treatments demonstrated statistically significant improvements in FEV1 AUC0-24 response at 3 weeks versus placebo (p?

SUBMITTER: Beeh KM 

PROVIDER: S-EPMC4509767 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature