Table 1.
Assessment tools used in patient-reported data collection
| Assessment tools | Time points completeda | Summary |
|---|---|---|
| E-RS: COPD [15, 16] | Daily |
11 respiratory symptom items contained in the 14-item EXACT Total score represents overall respiratory symptom severity and the three subscales assess breathlessness, cough and sputum, and chest-related symptoms MCID: ≥ 2-unit improvement (decrease) from baseline for total score |
| CAT [20, 21] | Baseline, day 1, weeks 4 and 24, week 52 (EXT) |
Eight items, each with a 6-point response scale, ranging from 0 (no impact) to 5 (high impact) with a scoring range of 0–40 MCID ≥ 2-unit improvement (decrease in score) from baseline |
| Rescue medication use | Daily | Number of occasions of rescue medication use per day |
| TDI focal score [17–19] | Weeks 4 and 24, week 52 (EXT) |
Change in dyspnea severity on a 7-point scale ranging from major deterioration to major improvement MCID: ≥ 1-unit improvement (increase) |
| SGRQ-C [14] | Day 1, week 4 and 24, week 52 (EXT) |
40 items weighted by symptoms, activity, and impacts with a scoring range of 0–100 Domain scores are calculable for symptoms, activity, and impact MCID ≥ 4-unit improvement (decrease in score) from baseline |
| Global rating of COPD severity | Baseline, week 24, and 52 (EXT) |
4-point scale (mild, moderate, severe, very severe) Change rated on a 7-point Likert scale (much better, better, slightly better, no change, slightly worse, worse, much worse) |
| Rating of change in COPD severity | All study visits following baseline | |
| Daily activity question | Baseline, week 24, and 52 (EXT) | 3-point scale: 0 = I did fewer activities than usual; 1 = There was no effect on my activities; 2 = I did more activities than usual |
| Global rating of activity limitation | Baseline, week 24, and 52 (EXT) |
Activity limitation rated on a 4-point scale (not limited, slightly limited, limited, very limited) Change rated on a 7-point Likert scale (much better, better, slightly better, no change, slightly worse, worse, much worse) |
| Rating of change in activity limitation | All study visits following baseline | |
| CIPQ | Week 24 (or study treatment discontinuation visit) | Three questions regarding number of steps, time taken, and ease of use |
CAT COPD Assessment Test, CIPQ COPD Inhaler Preference Questionnaire, COPD chronic obstructive pulmonary disease, E-RS: COPD Evaluating Respiratory Symptoms in COPD, EXACT EXAcerbations of Chronic pulmonary disease Tool, EXT extension, MCID minimal clinically important difference, SGRQ-C St George’s Respiratory Questionnaire for COPD, TDI Transition Dyspnea Index
aAll time points specified are for the ITT population, unless otherwise specified