Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Phase 4 Completed 457 enrolled Boehringer Ingelheim Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Timeline

Start: 2007-04
Primary completion: 2010-07
Completion: —

Outcome

Met primary endpoint

registry Placebo vs Tiotropium; p <0.001; Mean Difference (Final Values) 0.23 (95% CI 0.18 to 0.27) NCT00523991 ↗

paper Tiotropium was superior to placebo in mean change from baseline in post-dose FEV1 area under the curve PMID 24841833 ↗

Publications

Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3.

Drugs

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