A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

Summary

This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

Timeline

Start

2011-03

Primary completion

2011-12

Completion

—

Outcome

Met primary endpoint

paper All olodaterol treatments demonstrated statistically significant improvements in FEV1 AUC0-24 response at 3 weeks versus placebo (p < 0.0001); PMID 26177937 ↗

registry Placebo vs Olo 2.5 mcg Bid; p <0.0001; Mean Difference (Final Values) 0.191 (95% CI 0.152 to 0.229) NCT01311661 ↗

registry Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.150 (95% CI 0.111 to 0.189) NCT01311661 ↗

registry Placebo vs Olo 5 mcg Bid; p <0.0001; Mean Difference (Final Values) 0.228 (95% CI 0.190 to 0.266) NCT01311661 ↗

registry Placebo vs Olo 10 mcg qd; p <0.0001; Mean Difference (Final Values) 0.209 (95% CI 0.170 to 0.247) NCT01311661 ↗

Publications

• Beeh KM, LaForce C, Gahlemann M, Wenz A, Toorawa R, Flezar M. Randomised, double-blind, placebo-controlled crossover study to investigate different dosing regimens of olodaterol delivered via Respimat(R) in patients with moderate to severe persistent asthma. Respir Res. 2015 Jul 16;16(1):87. doi: 10.1186/s12931-015-0243-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	2.5 ug	Inhaled
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled

Indications