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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olodaterol | Small molecule | — | Inhaled |
| Subject | Tiotropium | Other / unclassified | — | Inhaled |