Table 3.
0–24-hour weighted mean FEV 1 (L) on Day 7 (mITT population)
| 0–24-hour weighted mean FEV 1 (L) | Placebo N = 60 |
UMEC QD |
|||
|---|---|---|---|---|---|
|
15.6 μg |
31.25 μg |
62.5 μg |
125 μg |
||
| N = 60 | N = 57 | N = 59 | N = 60 | ||
|
N |
54 |
56 |
51 |
54 |
56 |
| LS mean (SE) |
1.327 (0.018) |
1.443 (0.018) |
1.445 (0.019) |
1.459 (0.018) |
1.500 (0.018) |
| LS mean change (SE) |
−0.074 (0.018) |
0.043 (0.018) |
0.045 (0.019) |
0.059 (0.018) |
0.100 (0.018) |
| Difference from placebo |
NA |
0.116 |
0.118 |
0.132 |
0.173 |
| 95% CI |
NA |
(0.072, 0.160) |
(0.073, 0.163) |
(0.087, 0.178) |
(0.129, 0.217) |
|
p-value |
NA |
<0.001 |
<0.001 |
<0.001 |
<0.001 |
|
0–24-hour |
UMEC BID |
Tiotropium |
|||
|
weighted mean FEV
1
(L) |
15.6 μg |
31.25 μg |
QD 18 μg |
||
|
N = 56 |
N = 58 |
N = 56 |
|||
|
N |
52 |
55 |
53 |
||
| LS mean (SE) |
1.462 (0.018) |
1.469 (0.018) |
1.484 (0.018) |
||
| LS mean change (SE) |
0.062 (0.018) |
0.068 (0.018) |
0.084 (0.018) |
||
| Difference from placebo |
0.136 |
0.142 |
0.157 |
||
| 95% CI |
(0.091, 0.181) |
(0.098, 0.186) |
(0.113, 0.202) |
||
| p-value | <0.001 | <0.001 | <0.001 | ||
Note: Analysis performed using a mixed model with covariates of trough mean baseline, trough period baseline, treatment and period as fixed effects and subject as a random effect.
For each treatment period, baseline was defined as the mean of the values obtained 5 and 30 minutes predose on Day 1.
BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 second; LS, least square; mITT, modified intent-to-treat; NA, not applicable; QD, once daily; SE, standard error; UMEC, umeclidinium bromide.