A study to assess COPD symptom-based management and to optimise treatment strategy in Japan (COSMOS-J) based on GOLD 2011

Tomoko Betsuyaku, Motokazu Kato, Keisaku Fujimoto, Gerry Hagan, Akihiro Kobayashi, Hideki Hitosugi, Mark James, Paul W. Jones

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background and objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a COPD assessment framework focused on symptoms and on exacerbation risk. This study will evaluate a symptom and exacerbation risk-based treatment strategy based on GOLD in a real-world setting in Japan. Optimal management of COPD will be determined by assessing symptoms using the COPD Assessment Test (CAT) and by assessing the frequency of exacerbations. Methods: This study (ClinicalTrials.gov identifier: NCT01762800) is a 24-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. It aims to recruit 400 patients with moderate-to-severe COPD. Patients will be randomized to receive treatment with either salmeterol/fluticasone propionate (SFC) 50/250 μg twice daily or with tiotropium bromide 18 μg once daily. Optimal management of patients will be assessed at four-weekly intervals and, if patients remain symptomatic, as measured using the CAT, or experience an exacerbation, they have the option to step up to treatment with both drugs, ie, SFC twice daily and tiotropium once daily (TRIPLE therapy). The primary endpoint of the study will be the proportion of patients who are able to remain on the randomized therapy. Results: No data are available. This paper summarizes the methodology of the study in advance of the study starting. Conclusion: The results of this study will help physicians to understand whether TRIPLE therapy is more effective than either treatment strategy alone in controlling symptoms and exacerbations in patients with moderate-to-severe COPD. It will also help physicians to understand the GOLD recommendation work in Japan.

Original languageEnglish
Pages (from-to)453-459
Number of pages7
JournalInternational Journal of COPD
Volume8
DOIs
Publication statusPublished - 2013 Oct 2

Fingerprint

Chronic Obstructive Pulmonary Disease
Japan
Therapeutics
Physicians
Pharmaceutical Preparations

Keywords

  • COPD
  • Exacerbation risk
  • GOLD
  • Symptom
  • TRIPLE therapy

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Public Health, Environmental and Occupational Health
  • Health Policy

Cite this

A study to assess COPD symptom-based management and to optimise treatment strategy in Japan (COSMOS-J) based on GOLD 2011. / Betsuyaku, Tomoko; Kato, Motokazu; Fujimoto, Keisaku; Hagan, Gerry; Kobayashi, Akihiro; Hitosugi, Hideki; James, Mark; Jones, Paul W.

In: International Journal of COPD, Vol. 8, 02.10.2013, p. 453-459.

Research output: Contribution to journalArticle

Betsuyaku, T, Kato, M, Fujimoto, K, Hagan, G, Kobayashi, A, Hitosugi, H, James, M & Jones, PW 2013, 'A study to assess COPD symptom-based management and to optimise treatment strategy in Japan (COSMOS-J) based on GOLD 2011', International Journal of COPD, vol. 8, pp. 453-459. https://doi.org/10.2147/COPD.S48298
Betsuyaku, Tomoko ; Kato, Motokazu ; Fujimoto, Keisaku ; Hagan, Gerry ; Kobayashi, Akihiro ; Hitosugi, Hideki ; James, Mark ; Jones, Paul W. / A study to assess COPD symptom-based management and to optimise treatment strategy in Japan (COSMOS-J) based on GOLD 2011. In: International Journal of COPD. 2013 ; Vol. 8. pp. 453-459.
@article{6f06ac2f70a440c0a60fc9a14a7a7862,
title = "A study to assess COPD symptom-based management and to optimise treatment strategy in Japan (COSMOS-J) based on GOLD 2011",
abstract = "Background and objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a COPD assessment framework focused on symptoms and on exacerbation risk. This study will evaluate a symptom and exacerbation risk-based treatment strategy based on GOLD in a real-world setting in Japan. Optimal management of COPD will be determined by assessing symptoms using the COPD Assessment Test (CAT) and by assessing the frequency of exacerbations. Methods: This study (ClinicalTrials.gov identifier: NCT01762800) is a 24-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. It aims to recruit 400 patients with moderate-to-severe COPD. Patients will be randomized to receive treatment with either salmeterol/fluticasone propionate (SFC) 50/250 μg twice daily or with tiotropium bromide 18 μg once daily. Optimal management of patients will be assessed at four-weekly intervals and, if patients remain symptomatic, as measured using the CAT, or experience an exacerbation, they have the option to step up to treatment with both drugs, ie, SFC twice daily and tiotropium once daily (TRIPLE therapy). The primary endpoint of the study will be the proportion of patients who are able to remain on the randomized therapy. Results: No data are available. This paper summarizes the methodology of the study in advance of the study starting. Conclusion: The results of this study will help physicians to understand whether TRIPLE therapy is more effective than either treatment strategy alone in controlling symptoms and exacerbations in patients with moderate-to-severe COPD. It will also help physicians to understand the GOLD recommendation work in Japan.",
keywords = "COPD, Exacerbation risk, GOLD, Symptom, TRIPLE therapy",
author = "Tomoko Betsuyaku and Motokazu Kato and Keisaku Fujimoto and Gerry Hagan and Akihiro Kobayashi and Hideki Hitosugi and Mark James and Jones, {Paul W.}",
year = "2013",
month = "10",
day = "2",
doi = "10.2147/COPD.S48298",
language = "English",
volume = "8",
pages = "453--459",
journal = "International Journal of COPD",
issn = "1176-9106",
publisher = "Dove Medical Press Ltd.",

}

TY - JOUR

T1 - A study to assess COPD symptom-based management and to optimise treatment strategy in Japan (COSMOS-J) based on GOLD 2011

AU - Betsuyaku, Tomoko

AU - Kato, Motokazu

AU - Fujimoto, Keisaku

AU - Hagan, Gerry

AU - Kobayashi, Akihiro

AU - Hitosugi, Hideki

AU - James, Mark

AU - Jones, Paul W.

PY - 2013/10/2

Y1 - 2013/10/2

N2 - Background and objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a COPD assessment framework focused on symptoms and on exacerbation risk. This study will evaluate a symptom and exacerbation risk-based treatment strategy based on GOLD in a real-world setting in Japan. Optimal management of COPD will be determined by assessing symptoms using the COPD Assessment Test (CAT) and by assessing the frequency of exacerbations. Methods: This study (ClinicalTrials.gov identifier: NCT01762800) is a 24-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. It aims to recruit 400 patients with moderate-to-severe COPD. Patients will be randomized to receive treatment with either salmeterol/fluticasone propionate (SFC) 50/250 μg twice daily or with tiotropium bromide 18 μg once daily. Optimal management of patients will be assessed at four-weekly intervals and, if patients remain symptomatic, as measured using the CAT, or experience an exacerbation, they have the option to step up to treatment with both drugs, ie, SFC twice daily and tiotropium once daily (TRIPLE therapy). The primary endpoint of the study will be the proportion of patients who are able to remain on the randomized therapy. Results: No data are available. This paper summarizes the methodology of the study in advance of the study starting. Conclusion: The results of this study will help physicians to understand whether TRIPLE therapy is more effective than either treatment strategy alone in controlling symptoms and exacerbations in patients with moderate-to-severe COPD. It will also help physicians to understand the GOLD recommendation work in Japan.

AB - Background and objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a COPD assessment framework focused on symptoms and on exacerbation risk. This study will evaluate a symptom and exacerbation risk-based treatment strategy based on GOLD in a real-world setting in Japan. Optimal management of COPD will be determined by assessing symptoms using the COPD Assessment Test (CAT) and by assessing the frequency of exacerbations. Methods: This study (ClinicalTrials.gov identifier: NCT01762800) is a 24-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. It aims to recruit 400 patients with moderate-to-severe COPD. Patients will be randomized to receive treatment with either salmeterol/fluticasone propionate (SFC) 50/250 μg twice daily or with tiotropium bromide 18 μg once daily. Optimal management of patients will be assessed at four-weekly intervals and, if patients remain symptomatic, as measured using the CAT, or experience an exacerbation, they have the option to step up to treatment with both drugs, ie, SFC twice daily and tiotropium once daily (TRIPLE therapy). The primary endpoint of the study will be the proportion of patients who are able to remain on the randomized therapy. Results: No data are available. This paper summarizes the methodology of the study in advance of the study starting. Conclusion: The results of this study will help physicians to understand whether TRIPLE therapy is more effective than either treatment strategy alone in controlling symptoms and exacerbations in patients with moderate-to-severe COPD. It will also help physicians to understand the GOLD recommendation work in Japan.

KW - COPD

KW - Exacerbation risk

KW - GOLD

KW - Symptom

KW - TRIPLE therapy

UR - http://www.scopus.com/inward/record.url?scp=84885039844&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84885039844&partnerID=8YFLogxK

U2 - 10.2147/COPD.S48298

DO - 10.2147/COPD.S48298

M3 - Article

C2 - 24124358

AN - SCOPUS:84885039844

VL - 8

SP - 453

EP - 459

JO - International Journal of COPD

JF - International Journal of COPD

SN - 1176-9106

ER -