Background: Clinical information on 24-h spirometric efficacy of combining tiotropium and salmeterol compared to single-agent therapy is lacking in patients with COPD.
Methods: A randomized, double-blind, four-way crossover study of 6-week treatment periods comparing combination therapy of tiotropium 18 mu g plus qd or bid salmeterol 50 mu g versus single-agent therapy. Serial 24-h spirometry (FEV(1), FVC), effects on dyspnea (TDI focal score) and rescue salbutamol use were evaluated in 95 patients.
Results: Tiotropium plus qd salmeterol was superior to tiotropium or salmeterol alone in average FEV(1) (0-24 h) by 72 mL and 97 mL (p <0.0001), respectively. Compared to this qd regimen, combination therapy including bid salmeterol provided comparable daytime (0-12 h: 12 mL, p = 0.38) bronchodilator effects, but significantly more bronchodilation during the night-time (12-24 h: 73 mL, p
Conclusion: Compared to single-agent therapy, combination therapy of tiotropium plus salmeterol in COPD provided clinically meaningful improvements in airflow obstruction and dyspnea as well as a reduction in reliever medication. (C) 2010 Elsevier Ltd. All rights reserved.