Table 2.
Change from baseline in trough FEV1 on Day 7 (pooled population)
| Parameter | Placebo | Glycopyrrolate | Aclidinium | |||||
|---|---|---|---|---|---|---|---|---|
| (n = 149) | 3 μg BID (n = 91) |
6.25 μg BID (n = 92) |
12.5 μg BID (n = 145) |
25 μg BID (n = 54) |
50 μg BID (n = 149) |
100 μg BID (n = 59) |
400 μg BID (n = 94) |
|
| Baseline FEV1 | ||||||||
| n | 149 | 91 | 92 | 144 | 54 | 149 | 59 | 94 |
| Mean (SD), L | 1.296 (0.429) | 1.363 (0.429) | 1.380 (0.440) | 1.302 (0.421) | 1.205 (0.425) | 1.321 (0.433) | 1.202 (0.463) | 1.395 (0.464) |
| FEV1 on Day 7 | ||||||||
| n | 139 | 86 | 88 | 137 | 51 | 139 | 57 | 86 |
| Mean (SD), L | 1.304 (0.419) | 1.375 (0.422) | 1.454 (0.482) | 1.396 (0.435) | 1.313 (0.434) | 1.436 (0.440) | 1.359 (0.491) | 1.508 (0.434) |
| Change from baseline in FEV1 on Day 7 | ||||||||
| Mean (SD), L | −0.024 (0.214) | −0.012 (0.186) | 0.063 (0.200) | 0.100 (0.193) | 0.108 (0.202) | 0.113 (0.214) | 0.154 (0.170) | 0.120 (0.187) |
| LS mean (SE), L | −0.024 (0.017) | −0.007 (0.021) | 0.068 (0.021) | 0.097 (0.017) | 0.099 (0.028) | 0.113 (0.017) | 0.145 (0.026) | 0.125 (0.021) |
| 95% CI | −0.057, 0.009 | −0.049, 0.034 | 0.026, 0.109 | 0.064, 0.131 | 0.045, 0.153 | 0.081, 0.146 | 0.094, 0.196 | 0.083, 0.167 |
| Placebo-adjusted change from baseline in FEV1 on Day 7 | ||||||||
| LS mean (SE), L | – | 0.017 (0.027) | 0.092 (0.027) | 0.122 (0.024) | 0.123 (0.032) | 0.137 (0.024) | 0.169 (0.031) | 0.149 (0.027) |
| 95% CI | – | −0.036, 0.070 | 0.039, 0.144 | 0.075, 0.168 | 0.060, 0.186 | 0.091, 0.184 | 0.108, 0.230 | 0.096, 0.202 |
BID twice daily, CI confidence interval, FEV 1 forced expiratory volume in 1 s, LS least squares, SD standard deviation, SE standard error