Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: A randomized controlled study
- Authors
- Jung, Ki Suck; Park, Hye Yun; Park, So Young; Kim, Se Kyu; Kim, Young-Kyoon; Shim, Jae-Jeong; Moon, Hwa Sik; Lee, Kwan Ho; Yoo, Jee-Hong; Lee, Sang Do
- Issue Date
- 3월-2012
- Publisher
- W B SAUNDERS CO LTD
- Keywords
- Chronic obstructive pulmonary disease; Lung function; Tiotropium; Fluticasone propionate/salmeterol
- Citation
- RESPIRATORY MEDICINE, v.106, no.3, pp.382 - 389
- Indexed
- SCIE
SCOPUS
- Journal Title
- RESPIRATORY MEDICINE
- Volume
- 106
- Number
- 3
- Start Page
- 382
- End Page
- 389
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/105350
- DOI
- 10.1016/j.rmed.2011.09.004
- ISSN
- 0954-6111
- 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.
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