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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Tiotropium 5 μg vs Tiotropium + Olodaterol 5/5 μg; p <0.001; Mean Difference (Final Values) 0.115 (95% CI 0.077 to 0.153) NCT02629965 ↗

Publications

• Minakata Y, Motegi T, Ueki J, Gon Y, Nakamura S, Anzai T, Hirata K, Ichinose M. Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO(R) study. Int J Chron Obstruct Pulmon Dis. 2019 Aug 7;14:1789-1801. doi: 10.2147/COPD.S208081. eCollection 2019.

Drugs

Indications