drugset / Trial / NCT02969317

Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients

NCT02969317

Phase 1 Completed 12 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess the pharmacokinetics of tiotropium + olodaterol fixed-dose combination (FDC) (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after single dose and at steady state in Chinese patients with COPD. The secondary objective is to assess the safety of tiotropium + olodaterol FDC (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Chinese patients with COPD.

Timeline

Start
2017-02-24
Primary completion
2017-06-15
Completion
2017-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Olodaterol Small molecule 5 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled