The effect of tiotropium on exacerbations and airflow in patients with COPD

Abstract

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±sdnumber 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·min⁻¹and 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%versusplacebo. Tiotropium also decreased HRUversusplacebo, 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 tiotropiumversusplacebo 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 capacityversusplacebo.In conclusion, tiotropium reduced exacerbations and associated health resource use, and improved airflow over 1 yr in chronic obstructive pulmonary disease patients.