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Randomized Controlled Trial
. 2008 Sep;17(3):169-75.
doi: 10.3132/pcrj.2008.00037.

Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD

Gunnar Johansson  1 , Anne Lindberg, Kerstin Romberg, Lars Nordström, Fronke Gerken, Annika Roquet
Affiliations
Randomized Controlled Trial

Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD

Gunnar Johansson et al. Prim Care Respir J. 2008 Sep.

Abstract

Aims: Evaluation of tiotropium efficacy in patients with mild chronic obstructive pulmonary disease (COPD) defined by the 2003 Swedish Society of Respiratory Medicine guidelines (post-bronchodilator FEV1/FVC <70%; FEV1 >60% predicted).

Methods: In this 12-week, randomised, double-blind, placebo-controlled study of tiotropium 18 mcg once daily versus placebo, respiratory function was assessed on Days 1, 15 and 85 (baseline: pre-dose Day 1).

Results: Mean+/-SD baseline FEV1 (% predicted) was 73.4+/-12.5 (tiotropium, n=107; placebo, n=117). Tiotropium significantly improved change from baseline in area under the curve from pre-dose to 2 hours post-dose (AUC0-2 h) FEV1 versus placebo, by 166+/-26 mL (mean+/-SE) at study end (p<0.0001). With tiotropium, there were significant increases in the change in AUC0-2 h FVC versus baseline, and trough FEV1 and FVC, versus placebo, on all test days (p<0.01). Adverse event rates were similar.

Conclusion: Compared with placebo, tiotropium improved lung function in patients with mild COPD.

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