Tiotropium In Exercise

Phase 4 Completed 519 enrolled Boehringer Ingelheim Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

Timeline

Start: 2007-08
Primary completion: 2010-06
Completion: —

Outcome

Missed primary endpoint

registry Placebo vs Tiotropium; p = 0.1062; Adjusted mean ratio 1.13 (95% CI 0.97 to 1.32) NCT00525512 ↗

paper However, the 96-week difference was not statistically significant. PMID 23558890 ↗

Publications

Cooper CB, Celli BR, Jardim JR, Wise RA, Legg D, Guo J, Kesten S. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tiotropium	Other / unclassified	18 ug	Inhaled