The 24-h FEV1 time profile of olodaterol QD delivered via Respimat® in COPD: Results from two 6-week studies

Abstract

Background: Olodaterol (O) is a novel inhaled LABA. Objective: To evaluate the 24-h lung function profile of O QD in patients (pts) with GOLD 2-4 COPD. Methods: In two replicate, randomised, double-blind, placebo (P)-controlled, 6-week (wk), crossover studies, pts received O (5 or 10 µg) QD via Respimat®, tiotropium (T; 18 µg) QD via HandiHaler® or P for 6 wks (Study 1: [NCT01040689][1]; Study 2: [NCT01040728][2]). Pts continued with ICS and xanthines as background therapy. Co-primary end points were change from study baseline (response) in FEV1 AUC0-12 and FEV1 AUC12-24; secondary end points were FEV1 AUC0-3, FEV1 AUC0-24 and trough FEV1 response after 6 wks of treatment. Results: 108 and 122 pts were treated in Studies 1 and 2, respectively. Significant bronchodilation vs P was evident over the full 24-h dosing interval for O and T QD. ![Figure][3] Statistically significant (p<0.001) improvements were observed in all lung function end points with O 5 and 10 µg and T vs P. View this table: Conclusions: These data confirm the 24-h lung function efficacy profile of O QD. Funding: Boehringer Ingelheim. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01040689&atom=%2Ferj%2F42%2FSuppl_57%2F4635.atom [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01040728&atom=%2Ferj%2F42%2FSuppl_57%2F4635.atom [3]: pending:yes