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

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

Research output: Contribution to journalArticle

53 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)382-389
Number of pages8
JournalRespiratory Medicine
Volume106
Issue number3
DOIs
Publication statusPublished - 2012 Mar 1

Fingerprint

Chronic Obstructive Pulmonary Disease
Tiotropium Bromide
Salmeterol Xinafoate Drug Combination Fluticasone Propionate
Quality of Life
Bronchodilator Agents
Therapeutics
Pneumonia

Keywords

  • Chronic obstructive pulmonary disease
  • Fluticasone propionate/salmeterol
  • Lung function
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

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

In: Respiratory Medicine, Vol. 106, No. 3, 01.03.2012, p. 382-389.

Research output: Contribution to journalArticle

Jung, KS, Park, HY, Park, SY, Kim, SK, Kim, YK, Shim, JJ, Moon, HS, Lee, KH, Yoo, JH & Lee, SD 2012, 'Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: A randomized controlled study', Respiratory Medicine, vol. 106, no. 3, pp. 382-389. https://doi.org/10.1016/j.rmed.2011.09.004
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. / Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD : A randomized controlled study. In: Respiratory Medicine. 2012 ; Vol. 106, No. 3. pp. 382-389.
@article{1e3fe2b087244d7cbed3ee3426e8cd08,
title = "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 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.",
keywords = "Chronic obstructive pulmonary disease, Fluticasone propionate/salmeterol, Lung function, Tiotropium",
author = "Jung, {Ki Suck} and Park, {Hye Yun} and Park, {So Young} and Kim, {Se Kyu} and Kim, {Young Kyoon} and Shim, {Jae Jeong} and Moon, {Hwa Sik} and Lee, {Kwan Ho} and Yoo, {Jee Hong} and Lee, {Sang Do}",
year = "2012",
month = "3",
day = "1",
doi = "10.1016/j.rmed.2011.09.004",
language = "English",
volume = "106",
pages = "382--389",
journal = "Respiratory Medicine",
issn = "0954-6111",
publisher = "W.B. Saunders Ltd",
number = "3",

}

TY - JOUR

T1 - Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD

T2 - 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

PY - 2012/3/1

Y1 - 2012/3/1

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.

AB - 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.

KW - Chronic obstructive pulmonary disease

KW - Fluticasone propionate/salmeterol

KW - Lung function

KW - Tiotropium

UR - http://www.scopus.com/inward/record.url?scp=84855906419&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84855906419&partnerID=8YFLogxK

U2 - 10.1016/j.rmed.2011.09.004

DO - 10.1016/j.rmed.2011.09.004

M3 - Article

C2 - 21975275

AN - SCOPUS:84855906419

VL - 106

SP - 382

EP - 389

JO - Respiratory Medicine

JF - Respiratory Medicine

SN - 0954-6111

IS - 3

ER -