Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: A randomized controlled study

Abstract

Background: The combination of tiotropium and fluticasone propionate/salmeterol (FSC) is commonly used to treat chronic obstructive pulmonary disease (COPD), but no study had evaluated the effectiveness of tiotropium plus FSC with 250 mu g of fluticasone propionate. Our aim was to assess whether tiotropium (18 mu g once daily) plus FSC (250/50 mu g twice daily) provides better clinical outcomes compared to tiotropium monotherapy. Methods: In this 24-week, randomized, open label, multicenter two-arm parallel study, 479 patients received tiotropium plus FSC (n = 237) or tiotropium alone (n = 242). Results: After 24 weeks of treatment, the triple-inhaled treatment group had a significant improvement in pre-bronchodilator FEV1 (L) compared to the tiotropium-only group (0.090 L vs. 0.038 L; P = 0.005). Regarding health-related quality of life, the mean change in total score on the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) was -6.6 points in the tiotropium plus FSC group, but 1.5 points in the tiotropium-only group (P = 0.001). In the subgroup of GOLD stage II patients with COPD, treatment with tiotropium plus FSC also improved FEV1 compared to tiotropium alone (0.088 Lys. 0.030 L; P = 0.011) and improved the total SGRQ-C score than tiotropium alone (-4.5 points vs. -1.0 points, respectively). This triple-inhaled treatment approach did not induce more adverse events, such as pneumonia. Conclusion: Over the course of 24 weeks, FSC (250/50 mu g twice daily) added to tiotropium provided greater improvement in lung function and quality of life in patients with COPD (FEV1 <= 65%) than tiotropium alone. (C) 2011 Elsevier Ltd. All rights reserved.