Table 3.
Change from baseline in normalized AUC for FEV1 on Days 1 and 7
Placebo N = 15 | Abediterol 2.5 μg N = 14 | Abediterol 5 μg N = 14 | Abediterol 10 μg N = 14 | |
---|---|---|---|---|
LSM (SE) and 95% CI | ||||
Change from baseline in AUC FEV1 on Day 1, L | ||||
AUC0–6 | 0.176 (0.053) | 0.701 (0.070) | 0.747 (0.080) | 0.774 (0.090) |
(0.064, 0.289) | (0.552, 0.851) | (0.577, 0.917) | (0.584, 0.964) | |
AUC0–12 | 0.150 (0.057) | 0.683 (0.072) | 0.711 (0.080) | 0.759 (0.088) |
(0.029, 0.272) | (0.530, 0.835) | (0.541, 0.881) | (0.571, 0.946) | |
AUC0‐24 | 0.122 (0.054) | 0.627 (0.069) | 0.666 (0.076) | 0.707 (0.082) |
(0.009, 0.236) | (0.481, 0.772) | (0.505, 0.828) | (0.534, 0.879) | |
AUC12–24 | 0.096 (0.055) | 0.567 (0.067) | 0.621 (0.073) | 0.658 (0.078) |
(−0.021, 0.212) | (0.426, 0.708) | (0.466, 0.775) | (0.493, 0.823) | |
Change from baseline in AUC FEV1 on Day 7, L | ||||
AUC0–6 | 0.171 (0.091) | 0.593 (0.093) | 0.586 (0.096) | 0.554 (0.097) |
(−0.021, 0.363) | (0.395, 0.791) | (0.382, 0.789) | (0.348, 0.759) | |
AUC0–12 | 0.165 (0.086) | 0.565 (0.090) | 0.541 (0.092) | 0.500 (0.092) |
(−0.017, 0.347) | (0.374, 0.757) | (0.345, 0.736) | (0.306, 0.695) | |
AUC0–24 | 0.125 (0.084) | 0.517 (0.092) | 0.500 (0.093) | 0.428 (0.089) |
(−0.053, 0.302) | (0.322, 0.712) | (0.303, 0.697) | (0.239, 0.618) | |
AUC12–24 | 0.074 (0.080) | 0.454 (0.090) | 0.451 (0.092) | 0.356 (0.087) |
(−0.095, 0.244) | (0.262, 0.645) | (0.257, 0.645) | (0.171, 0.540) | |
AUC0–36 | 0.129 (0.081) | 0.484 (0.090) | 0.459 (0.090) | 0.390 (0.084) |
(−0.043, 0.301) | (0.293, 0.676) | (0.269, 0.650) | (0.212, 0.568) |
Baseline = predose measurement on Day 1.
AUC, area under the curve; CI, confidence interval; FEV1, forced expiratory volume in 1 sec; LSM, least squares mean; N, number of patients in the per protocol population (patients who completed all treatment periods and presented no serious violation of the protocol); SE, standard error.