Background: Olodaterol (O) is a novel LABA with 24-h bronchodilator activity.
Objective: To evaluate the efficacy of O QD in patients (pts) with GOLD 2-4 COPD.
Methods: In replicate, randomised, double-blind, placebo (P)-controlled, parallel-group studies, pts with post-bronchodilator FEV1 <80% predicted and FEV1/FVC <70% received O (5 or 10 µg) QD via Respimat®, formoterol (F; 12 μg) BID via Aerolizer® or P for 48 weeks (wks; A: [NCT00793624][1]; B: [NCT00796653][2]). Pts continued to receive usual care background COPD maintenance therapy including SAMA, LAMA, ICS and xanthines. Co-primary lung function end points were change from study baseline (response) in FEV1 AUC0-3 and trough FEV1 after 24 wks.
Results: 904 (A) and 934 (B) pts were treated. O 5 and 10 μg and F provided statistically significant improvements in co-primary end points after 24 wks vs P; there were no significant differences between O and F.
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Results were consistent for co-primary end points over 48 wks.
Conclusions: O 5 and 10 µg QD significantly improved lung function vs P over 48 wks. Response magnitude was comparable to F BID and in line with expectations for a QD bronchodilator considering the pt population and concomitant therapy.
Funding: Boehringer Ingelheim.
[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00793624&atom=%2Ferj%2F42%2FSuppl_57%2FP764.atom
[2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00796653&atom=%2Ferj%2F42%2FSuppl_57%2FP764.atom
[3]: pending:yes