drugset / Trial / NCT00578968
Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is being done to examine the influence of Tiotropium (good or bad) on heart function at rest and during exercise in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2006-10
- Primary completion
- 2008-08
- Completion
- 2008-08
Outcome
Missed primary endpoint
registry MEAN Tiotropium: 5.34 (Standard Deviation 1.39) L/min/m^2 MEAN Placebo: 6.70 (Standard Deviation 1.66) L/min/m^2 NCT00578968 ↗
registry analysis (superiority or other test); Tiotropium vs Placebo; p = 0.04; ANOVA NCT00578968 ↗
registry MEAN Tiotropium: 44.62 (Standard Deviation 9.0) mL/m^2 MEAN Placebo: 50.06 (Standard Deviation 12.49) mL/m^2 NCT00578968 ↗
registry analysis (superiority or other test); Tiotropium vs Placebo; p = 0.19; ANOVA NCT00578968 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiotropium | Other / unclassified | 18 ug | Inhaled |