Table 2 Results from the analyses of the primary, secondary and selected other endpoints (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) |
|---|---|---|
Primary endpoint | ||
wm 0–24 h FEV1 on Day 84, L | ||
n | 332 | 337 |
LS mean (SE) | 1.618 (0.0122) | 1.539 (0.0121) |
LS mean (SE) change from baseline | 0.166 (0.0122) | 0.087 (0.0121) |
Treatment difference (95 % CI) | 0.080 (0.046–0.113) | |
p < 0.001 | ||
Secondary endpoint | ||
Trough FEV1 on Day 85, L | ||
n | 344 | 353 |
n a | 333 | 338 |
LS mean (SE) | 1.600 (0.0126) | 1.511 (0.0125) |
LS mean (SE) change from baseline | 0.151 (0.0126) | 0.062 (0.0125) |
Treatment difference (95 % CI) | 0.090 (0.055–0.125) | |
p < 0.001 | ||
Other endpoints (selected) | ||
Peak FEV1 0–6 h | ||
Day 1 | ||
n | 358 | 358 |
n a | 358 | 358 |
LS mean (SE) | 1.712 (0.0083) | 1.678 (0.0083) |
LS mean (SE) change from baseline | 0.266 (0.0083) | 0.231 (0.0083) |
Treatment difference (95 % CI) | 0.034 (0.011–0.057) | |
p = 0.003 | ||
Day 84 | ||
n | 358 | 358 |
n a | 335 | 340 |
LS mean (SE) | 1.773 (0.0131) | 1.676 (0.0130) |
LS mean (SE) change from baseline | 0.327 (0.0131) | 0.229 (0.0130) |
Treatment difference (95 % CI) | 0.097 (0.061–0.134) | |
p < 0.001 | ||
Time to onset on Day 1 (increase in FEV1 ≥ 0.100 L above baseline) | ||
n | 358 | 358 |
Median time to onset, min | 17 | 60 |
Hazard ratio (95 % CI) | 1.3 (1.1–1.5) | |
p = 0.002 | ||