Table 4 Results for symptomatic endpoints and health outcome measures (ITT population)
From: Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial
Endpoint | UMEC/VI 62.5/25 mcg (N = 358) | FP/SAL 500/50 mcg (N = 358) |
|---|---|---|
Rescue salbutamol use | ||
Mean number of puffs/day, weeks 1–12 | ||
n | 334 | 349 |
LS mean (SE) | 1.3 (0.08) | 1.4 (0.08) |
LS mean (SE) change from baseline | −1.3 (0.08) | −1.2 (0.08) |
Treatment difference (95 % CI) | −0.1 (−0.3–0.1) | |
p = 0.559 | ||
Percent rescue-free days during 12 weeks, change from baseline | ||
n | 334 | 349 |
Mean (SD), (%) | 24.5 (36.38) | 23.5 (36.95) |
TDI focal score | ||
n a | 344 | 351 |
Day 28 | ||
n | 343 | 350 |
LS mean (SE) | 1.7 (0.13) | 1.6 (0.13) |
Treatment difference (95 % CI) | 0.2 (−0.2–0.5) | |
p = 0.369 | ||
Day 56 | ||
n | 336 | 343 |
LS mean (SE) | 2.0 (0.12) | 1.7 (0.12) |
Treatment difference (95 % CI) | 0.3 (0.0–0.6) | |
p = 0.078 | ||
Day 84 | ||
n | 334 | 338 |
LS mean (SE) | 2.0 (0.14) | 2.1 (0.13) |
Treatment difference (95 % CI) | −0.1 (−0.4–0.3) | |
p = 0.702 | ||
SGRQ Total score, change from baseline | ||
n a | 339 | 349 |
Day 28 | ||
n | 337 | 347 |
LS mean (SE) | 41.25 (0.552) | 40.03 (0.544) |
LS mean change (SE) | −3.83 (0.552) | −5.05 (0.544) |
Treatment difference (95 % CI) | 1.22 (−0.30–2.75) | |
p = 0.116 | ||
Day 84 | ||
n | 329 | 336 |
LS mean (SE) | 39.98 (0.626) | 39.44 (0.619) |
LS mean change (SE) | −5.10 (0.626) | −5.64 (0.619) |
Treatment difference (95 % CI) | 0.53 (−1.20–2.26) | |
p = 0.545 | ||
EQ-5D utility score on Day 84, change from baseline | ||
n | 335 | 341 |
Mean (SD) | 0.03 (0.189) | 0.03 (0.203) |
CAT score on Day 84, change from baseline | ||
n | 335 | 341 |
Mean (SD) | −2.21 (6.054) | −2.35 (6.432) |