• Prim Care Respir J · Sep 2008

    Randomized Controlled Trial Multicenter Study

    Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD.

    • Gunnar Johansson, Anne Lindberg, Kerstin Romberg, Lars Nordström, Fronke Gerken, and Annika Roquet.
    • Nyby Healthcare Centre and Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden. gunnar.johansson@pubcare.uu.se
    • Prim Care Respir J. 2008 Sep 1; 17 (3): 169-75.

    AimsEvaluation 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).MethodsIn 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).ResultsMean+/-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.ConclusionCompared with placebo, tiotropium improved lung function in patients with mild COPD.

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