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 μg of fluticasone propionate. Our aim was to assess whether tiotropium (18 μg once daily) plus FSC (250/50 μg 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 L vs. 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 μg twice daily) added to tiotropium provided greater improvement in lung function and quality of life in patients with COPD (FEV1 ≤ 65%) than tiotropium alone.

Author : Ki Suck Jung, Hye Yun Park, So Young Park, Se Kyu Kim, Young-Kyoon Kim, Jae-Jeong Shim, Hwa Sik Moon, Kwan Ho Lee, Jee-Hong Yoo, Sang Do Lee
Source : Respiratory Medicine, Volume 106, Issue 3
Read Full Article