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Canadian Respiratory Journal
Volume 14, Issue 8, Pages 465-472
Original Article

A Randomized Controlled Trial to Assess the Efficacy of Tiotropium in Canadian Patients with Chronic Obstructive Pulmonary Disease

Charles KN Chan,1 François Maltais,2 Chris Sigouin,3 Jennifer M Haddon,4 Gordon T Ford,5 and on behalf of the SAFE Study Group

1University Health Network – Toronto General Hospital, Toronto, Ontario, Canada
2Centre de recherche de l’Hôpital Laval, Institut universitaire de cardiologie et de pneumologie de l’Université Laval, Laval, Québec, Canada
3University of Toronto, Department of Health Policy, Management and Evaluation, Toronto, Canada
4Boehringer Ingelheim Canada Limited, Burlington, Ontario, Canada
5Respiratory Division, University of Calgary, Calgary, Alberta, Canada

Copyright © 2007 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) who smoke have a greater annual rate of decline in forced expiratory volume in 1 s (FEV1) than those patients who have stopped smoking.

OBJECTIVES: To assess the effect of tiotropium on pre-dose (trough) FEV1 in patients with COPD followed in Canada.

METHODS: A total of 913 patients were randomly assigned to receive either tiotropium 18 μg once daily (n=608) or placebo (usual care minus inhaled anticholinergics) (n=305) for 48 weeks in the present randomized, double-blind, parallel-group study. The effect of tiotropium on measurements of lung function (FEV1, FEV6 and forced vital capacity), symptoms, health-related quality of life (St George’s Respiratory Questionnaire) and exacerbations were examined.

RESULTS: Tiotropium improved trough FEV1 in both current and ex-smokers compared with placebo. Baseline FEV1 in smokers and ex-smokers was 1.03 L and 0.93 L, respectively (P<0.001). At week 48, the mean difference between the tiotropium and placebo groups was 0.14±0.04 L (P<0.001) in the smoker group and 0.08±0.02 L (P<0.0001) in the ex-smoker group. Tiotropium also significantly improved trough forced vital capacity and FEV6 compared with placebo throughout the treatment period (P<0.05, for all). Furthermore, tiotropium significantly improved the St George’s Respiratory Questionnaire total score compared with placebo at week 48 (40.9 versus 43.7 units, P<0.005).

CONCLUSIONS: Compared with the placebo group, tiotropium provides sustained improvements in lung function in patients with COPD, with improvements for smokers and ex-smokers.