title: A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011.
abstract: OBJECTIVE
  The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a chronic obstructive pulmonary disease (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Pulmonary Medicine, Department of Medicine, Keio University, Tokyo, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Betsuyaku
authors.forename: Motokazu
authors.initials: M
authors.lastname: Kato
authors.forename: Keisaku
authors.initials: K
authors.lastname: Fujimoto
authors.forename: Gerry
authors.initials: G
authors.lastname: Hagan
authors.forename: Akihiro
authors.initials: A
authors.lastname: Kobayashi
authors.forename: Hideki
authors.initials: H
authors.lastname: Hitosugi
authors.forename: Mark
authors.initials: M
authors.lastname: James
authors.forename: Paul W
authors.initials: PW
authors.lastname: Jones
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use*; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018680:Cholinergic Antagonists / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012107:Research Design; D012602:Scopolamine Derivatives / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D000069447:Tiotropium Bromide; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D012602:Scopolamine Derivatives; D000420:Albuterol; D000069447:Tiotropium Bromide
keywords: COPD; GOLD; TRIPLE therapy; exacerbation risk; symptom