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Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study.
Respir Med. 2012 Mar; 106(3):382-9.RM

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 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 FEV(1) (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 FEV(1) 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 (FEV(1) ≤ 65%) than tiotropium alone.

Authors+Show Affiliations

Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, Pyeongchon-dong, Dongan-gu, Anyang-si, Gyeonggido, Republic of Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21975275

Citation

Jung, Ki Suck, et al. "Comparison of Tiotropium Plus Fluticasone Propionate/salmeterol With Tiotropium in COPD: a Randomized Controlled Study." Respiratory Medicine, vol. 106, no. 3, 2012, pp. 382-9.
Jung KS, Park HY, Park SY, et al. Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. Respir Med. 2012;106(3):382-9.
Jung, K. S., Park, H. Y., Park, S. Y., Kim, S. K., Kim, Y. K., Shim, J. J., Moon, H. S., Lee, K. H., Yoo, J. H., & Lee, S. D. (2012). Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. Respiratory Medicine, 106(3), 382-9. https://doi.org/10.1016/j.rmed.2011.09.004
Jung KS, et al. Comparison of Tiotropium Plus Fluticasone Propionate/salmeterol With Tiotropium in COPD: a Randomized Controlled Study. Respir Med. 2012;106(3):382-9. PubMed PMID: 21975275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. AU - Jung,Ki Suck, AU - Park,Hye Yun, AU - Park,So Young, AU - Kim,Se Kyu, AU - Kim,Young-Kyoon, AU - Shim,Jae-Jeong, AU - Moon,Hwa Sik, AU - Lee,Kwan Ho, AU - Yoo,Jee-Hong, AU - Lee,Sang Do, AU - ,, AU - ,, Y1 - 2011/10/04/ PY - 2011/05/26/received PY - 2011/09/15/revised PY - 2011/09/19/accepted PY - 2011/10/7/entrez PY - 2011/10/7/pubmed PY - 2012/4/4/medline SP - 382 EP - 9 JF - Respiratory medicine JO - Respir Med VL - 106 IS - 3 N2 - 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 FEV(1) (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 FEV(1) 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 (FEV(1) ≤ 65%) than tiotropium alone. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/21975275/Comparison_of_tiotropium_plus_fluticasone_propionate/salmeterol_with_tiotropium_in_COPD:_a_randomized_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(11)00329-5 DB - PRIME DP - Unbound Medicine ER -