a. | |||||
---|---|---|---|---|---|
Morning dose: | UMEC QD | ||||
0–12-hour | Placebo | 15.6 μg | 31.25 μg | 62.5 μg | 125 μg |
weighted mean FEV1(L) | N = 60 | N = 60 | N = 57 | N = 59 | N = 60 |
N | 54 | 58 | 52 | 56 | 56 |
LS mean (SE) | 1.353 (0.019) | 1.467 (0.019) | 1.478 (0.020) | 1.481 (0.019) | 1.526 (0.019) |
LS mean change (SE) | −0.046 (0.019) | 0.068 (0.019) | 0.078 (0.020) | 0.082 (0.019) | 0.126 (0.019) |
Difference from placebo | N/A | 0.114 | 0.124 | 0.128 | 0.172 |
95% CI | N/A | (0.066, 0.161) | (0.075, 0.173) | (0.079, 0.177) | (0.124, 0.220) |
p-value | N/A | <0.001 | <0.001 | <0.001 | <0.001 |
Morning dose: | UMEC BID | Tiotropium QD | |||
0–12-hour | 15.6 μg | 31.25 μg | 18 μg | ||
weighted mean FEV 1 (L) | N = 56 | N = 58 | N = 56 | ||
N | 52 | 55 | 53 | ||
LS mean (SE) | 1.483 (0.020) | 1.483 (0.019) | 1.530 (0.020) | ||
LS mean change (SE) | 0.084 (0.020) | 0.084 (0.019) | 0.130 (0.020) | ||
Difference from placebo | 0.130 | 0.130 | 0.176 | ||
95% CI | (0.081, 0.178) | (0.081, 0.178) | (0.128, 0.224) | ||
p-value | <0.001 | <0.001 | <0.001 | ||
b. | |||||
Evening dose: | Placebo | UMEC QD | |||
12–24-hour | 15.6 μg | 31.25 μg | 62.5 μg | 125 μg | |
weighted mean FEV 1 (L) | N = 60 | N = 60 | N = 57 | N = 59 | N = 60 |
n | 54 | 56 | 52 | 54 | 56 |
LS mean (SE) | 1.298 (0.020) | 1.410 (0.020) | 1.410 (0.020) | 1.433 (0.020) | 1.470 (0.020) |
LS mean change (SE) | −0.103 (0.020) | 0.010 (0.020) | 0.010 (0.020) | 0.032 (0.020) | 0.069 (0.020) |
Difference from placebo | N/A | 0.112 | 0.112 | 0.135 | 0.172 |
95% CI | N/A | (0.064, 0.160) | (0.063, 0.162) | (0.085, 0.184) | (0.123, 0.221) |
p-value | N/A | <0.001 | <0.001 | <0.001 | <0.001 |
Evening dose: | UMEC BID | Tiotropium QD | |||
12–24-hour | 15.6 μg | 31.25 μg | 18 μg | ||
weighted mean FEV 1 (L) | N = 56 | N = 58 | N = 56 | ||
n | 52 | 55 | 53 | ||
LS mean (SE) | 1.440 (0.020) | 1.450 (0.020) | 1.437 (0.020) | ||
LS mean change (SE) | 0.039 (0.020) | 0.050 (0.020) | 0.036 (0.020) | ||
Difference from placebo | 0.141 | 0.152 | 0.138 | ||
95% CI | (0.092, 0.191) | (0.103, 0.201) | (0.090, 0.187) | ||
p-value | <0.001 | <0.001 | <0.001 |