Outcomes in COPD patients receiving tiotropium or salmeterol plus treatment with inhaled corticosteroids

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Authors: Richard Hodder, Steven Kesten, Shailendra Menjoge, Klaus Viel

Published Date August 2007 Volume 2007:2(2) Pages 157 - 167

DOI: http://dx.doi.org/10.2147/COPD.S

Richard Hodder¹, Steven Kesten², Shailendra Menjoge², Klaus Viel³

¹Divisions of Pulmonary and Critical Care Medicine, University of Ottawa, Canada; ²Boehringer Ingelheim, Ridgefield, Connecticut; ³Boehringer Ingelheim, Ingelheim, Germany

Abstract: Patients with COPD are frequently prescribed inhaled corticosteroids (ICS); however, it is unclear whether the treatment with ICS might modify responses to inhaled bronchodilators. Two 6-month, randomized, placebo-controlled, double-blind, double-dummy, parallel-group studies of tiotropium 18 µg once daily, compared with salmeterol, 50 µg bid, had been conducted in patients with moderate-to-severe COPD. Efficacy was assessed by spirometry, transition dyspnea index (TDI), St. George´s Respiratory Questionnaire (SGRQ), and exacerbations. Data from both studies were combined to form subgroups with regard to concurrent use of ICS. 796 patients receiving ICS were separately analyzed from 390 patients not receiving ICS. Mean age was 64 years, and pre-bronchodilator FEV₁ was 1.06 L (ICS group) and 1.13 L (non-ICS group). Both bronchodilators increased morning mean + SE pre-dose FEV₁ compared with placebo (ICS groups: tiotropium 110 + 20 mL, salmeterol 80 + 20 mL; non-ICS groups: tiotropium 150 + 30 mL, salmeterol 110 + 30 mL; p > 0.05 for tiotropium vs salmeterol). Improvements in TDI and SGRQ and frequency of exacerbations also tended to be more profound for tiotropium. Treatment with tiotropium in patients with moderate-to-severe COPD was superior to salmeterol in lung function, irrespective of concurrent use of ICS.

Keywords: chronic obstructive pulmonary disease, inhaled corticosteroids, salmeterol, tiotropium, fluticasone