At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 4 clinical trial evaluating FDC of tiotropium + olodaterol, Placebo, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 221 participants across 22 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Fixed Dose Combination of tiotropium + olodaterol