Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

Summary

This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study. Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.

Timeline

Start

2016-03-08

Primary completion

2017-01-09

Completion

2017-01-30

Drugs

Indications