Table 3.
Endpoint | UMEC/VI 62.5/25 mcg (N = 358) | FP/SAL 500/50 mcg (N = 358) |
---|---|---|
0–24 h wmFEV1 on Day 84, L, change from baseline | ||
GOLD B a,b | ||
n | 184 | 189 |
mean (SD) | 0.181 (0.2476) | 0.096 (0.2230) |
GOLD D b,c | ||
n | 148 | 148 |
mean (SD) | 0.152 (0.2111) | 0.071 (0.2038) |
Trough FEV1 on Day 85, L, change from baseline | ||
GOLD B a,b | ||
n | 185 | 189 |
mean (SD) | 0.162 (0.2661) | 0.070 (0.2340) |
GOLD D b,c | ||
n | 148 | 149 |
mean (SD) | 0.143 (0.2067) | 0.049 (0.2160) |
Descriptive analyses of change from baseline in 0–24 h wmFEV1 on Day 84 and in trough FEV1 on Day 85 by GOLD subgroup
FEV 1 forced expiratory volume in 1 s, FP/SAL fluticasone propionate/salmeterol, GOLD Global Initiative for Chronic Obstructive Lung Disease™, ITT intent-to-treat, SD standard deviation, UMEC umeclidinium, VI vilanterol, wm weighted mean
aFEV1 ≥ 50 % to <80 % predicted; bAll but three patients fulfilled the exclusion criterion regarding no exacerbations in the past year—no further details of exacerbation history were collected; cFEV1 ≥ 30 % to <50 % predicted