A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale
Summary
To demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with optimal and sub-optimal Peak Inspiratory Flow Rate (PIFR). Disease severity (moderate to severe) is based on the Global Initiative for Chronic Lung Disease (GOLD) guidelines (GOLD 2 - 3)
Timeline
- Start
- 2020-01-08
- Primary completion
- 2020-09-07
- Completion
- 2020-09-29
Outcome
Met primary endpoint
registry analysis (other test); Tio+Olo (5μg/5μg) - Sub-optimal PIFR vs Matching Placebo - Sub-optimal PIFR; p <0.0001; Difference of adjusted means 0.336 (95% CI 0.246 to 0.425); ANCOVA NCT04223843 ↗
registry analysis (other test); Tio+Olo (5μg/5μg ) - Optimal PIFR vs Matching Placebo - Optimal PIFR; p <0.0001; Difference of adjusted means 0.321 (95% CI 0.233 to 0.409); ANCOVA NCT04223843 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olodaterol | Small molecule | 5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 5 ug | Inhaled |