A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

Summary

The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.

Timeline

Start

2010-02

Primary completion

2011-01

Completion

2011-01

Outcome

Met primary endpoint

registry Placebo vs Olo 2 mcg qd; p <0.0001; Mean Difference (Final Values) 0.140 (95% CI 0.097 to 0.182) NCT01013753 ↗

paper statistically and clinically significant improvements versus placebo in FEV1 AUC0-24 responses at 4 weeks for all doses tested in Study 1222.27 PMID 26283085 ↗

Publications

• O'Byrne PM, D'Urzo T, Beck E, Flezar M, Gahlemann M, Hart L, Blahova Z, Toorawa R, Beeh KM. Dose-finding evaluation of once-daily treatment with olodaterol, a novel long-acting beta2-agonist, in patients with asthma: results of a parallel-group study and a crossover study. Respir Res. 2015 Aug 18;16(1):97. doi: 10.1186/s12931-015-0249-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Formoterol	Other / unclassified	12 ug	Inhaled
Subject	Olodaterol	Small molecule	2 ug	Inhaled
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Olodaterol	Small molecule	10 ug	Inhaled
Subject	Olodaterol	Small molecule	20 ug	Inhaled

Indications