drugset / Trial / NCT02629965

Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

NCT02629965

Phase 3 Completed 184 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.

Timeline

Start
2016-02-12
Primary completion
2017-03-24
Completion
2017-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Olodaterol Small molecule Inhaled
Comparator Tiotropium Other / unclassified Inhaled