Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Phase 3 Completed 1137 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

Timeline

Start: 2012-09
Primary completion: 2013-10
Completion: 2013-10

Outcome

Met primary endpoint

registry p <.0001; Mean Difference (Final Values) 0.106 (95% CI 0.078 to 0.135) NCT01696058 ↗

registry p = 0.0029; Mean Difference (Final Values) 0.040 (95% CI 0.014 to 0.065) NCT01696058 ↗

Publications

ZuWallack R, Allen L, Hernandez G, Ting N, Abrahams R. Efficacy and safety of combining olodaterol Respimat((R)) and tiotropium HandiHaler((R)) in patients with COPD: results of two randomized, double-blind, active-controlled studies. Int J Chron Obstruct Pulmon Dis. 2014 Oct 14;9:1133-44. doi: 10.2147/COPD.S72482. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Background	Tiotropium	Other / unclassified	18 ug	Inhaled