Volume 17 Issue 3 September 2008Original Research
Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD
Pages 169-175
*Gunnar Johanssona, Anne Lindbergb, Kerstin Rombergc, Lars Nordströmd, Fronke Gerkene, Annika Roquetd
a
Associate Professor, Nyby Healthcare Centre and Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden
b
Senior Consultant, The OLIN Studies and Division of Respiratory Medicine, Sunderby Hospital, Luleå, Sweden
c
General Practioner, Näset Healthcare Centre, Höllviken, Sweden
d
Clinical monitor, Boehringer Ingelheim AB, Stockholm, Sweden
e
Statistician, Boehringer Ingelheim Pharma GmbH & Co, Ingelheim, Germany
Received 21 December 2007 • Accepted 7 May 2008 • Online 6 June 2008
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.
Keywords
Chronic obstructive pulmonary disease, mild, moderate, tiotropium
* Corresponding author. Gunnar Johansson Tel: +46 18611 3427 Fax: +46 18511 657 Email: gunnar.johansson@pubcare.uu.se | |
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