Eur Respir J 2006; 27:547-555
Copyright ©ERS Journals Ltd 2006
The effect of tiotropium on exacerbations and airflow in patients with COPD
D. Dusser1,
M-L. Bravo2,
P. Iacono2 on behalf the MISTRAL study group1
1 Groupe Hôspitalier Cochin, Assistance Publique Hôpitaux de Paris, Faculté Cochin Port-Royal, Université Paris, Paris, and 2 Boehringer Ingelheim France, Reims, France.
CORRESPONDENCE: D. Dusser, Service de Pneumologie, Hôpital Cochin, 27 Rue du Faubourg Saint Jacques, 75679 Paris, Cedex 14, France. Fax: 33 146338253. E-mail: daniel.dusser{at}cch.aphp.fr
Keywords: Chronic obstructive pulmonary disease, exacerbations, health resource utilisation, peak expiratory flow, tiotropium
Received: May 30, 2005
Accepted December 6, 2005
This randomised, double-blind, parallel-group, 1-yr study compared the effect of tiotropium 18 µg once daily (n = 500) and placebo (n = 510) on exacerbations, associated health resource use (HRU) and airflow limitation in chronic obstructive pulmonary disease (COPD) patients.
The mean±SD number of exacerbations during the past year was 2.14±1.40, the mean weekly morning peak expiratory flow (PEF) was 259.6±96.1 L·min1 and the mean forced expiratory volume in one second (FEV1) was 1.37±0.45 L. Tiotropium significantly delayed the time to first exacerbation by 100 days, reduced the proportion of patients experiencing more than one exacerbation by 17%, and decreased the number of exacerbations by 35% and exacerbation days by 37% versus placebo. Tiotropium also decreased HRU versus placebo, as indicated by the significant reductions in the use of concomitant respiratory medications, antibiotics and oral steroids, and the number of unscheduled physician contacts. Mean weekly morning PEF improved significantly with tiotropium versus placebo from week 1 until the end of the study. At the end of the study, tiotropium significantly improved trough (pre-dose) FEV1, forced vital capacity, slow vital capacity and inspiratory capacity versus placebo.
In conclusion, tiotropium reduced exacerbations and associated health resource use, and improved airflow over 1 yr in chronic obstructive pulmonary disease patients.
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Copyright © 2006 by the European Respiratory Society.
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