Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Status:
Completed
Trial end date:
2017-01-30
Target enrollment:
Participant gender:
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.