drugset / Trial / NCT02030535

Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers

NCT02030535 ↗

Phase 2 Completed 53 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters

Timeline

Start
2014-01
Primary completion
2014-06
Completion
2014-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Tio+Olo 5/5μg; p <0.0001; Adjusted mean difference 0.219 (95% CI 0.187 to 0.252) NCT02030535 ↗

Drugs

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