A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011

Figures & data

Figure 1 Study design.

Abbreviations: SFC, salmeterol/fluticasone propionate; Tio, tiotropium bromide; TRIPLE, SFC twice daily and Tio once daily.

Table 1 Guidance for COPD control on randomized therapy

CAT/exacerbation	Guidance
CAT <10	“Your score suggests you are doing well. Are you satisfied with your current treatment?”
10≤ CAT ≤15	“Your score suggests your chest trouble is causing you some problems because [...]. Are you satisfied with your current treatment?”
CAT >15	“Your score clearly suggests your chest problem is having a big effect on you. We have an option to increase treatment. Do you want to try it?”
Moderate or severe COPD exacerbation	Switch to TRIPLE therapy

Abbreviations: CAT, COPD Assessment Test; SFC, salmeterol/fluticasone propionate; Tio, tiotropium bromide; TRIPLE, SFC twice daily and Tio once daily; COPD, chronic obstructive pulmonary disease.

Table 2 Secondary endpoints

Proportion of patients who switched to TRIPLE therapy

Proportion of patients controlled by TRIPLE therapy

Proportion of patients controlled by randomized therapy plus TRIPLE therapy

Time to switching to TRIPLE therapy

Time to first exacerbation

Proportion of exacerbation confirmed by EXACT

Proportion of exacerbations detected by EXACT not diagnosed

CAT score change

Change in FEV1

Use of relief medication

Proportion of patients who decreased treatment from TRIPLE therapy

Proportion of patients who required additional treatment to TRIPLE therapy

Proportion of patients who dropped out

Patient’s judgment of treatment efficacy

Physician’s judgment of treatment efficacy

Abbreviations: CAT, COPD Assessment Test; EXACT, EXAcerbations of Chronic Pulmonary Disease Tool; FEV₁, forced expiratory volume in 1 second; SFC, salmeterol/fluticasone propionate; TRIPLE, SFC twice daily and tiotropium once daily; COPD, chronic obstructive pulmonary disease.