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Table 2 Change from baseline in trough FEV1 on Day 7 (pooled population)

From: Dose selection for glycopyrrolate/eFlow® phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies

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
  1. BID twice daily, CI confidence interval, FEV 1 forced expiratory volume in 1 s, LS least squares, SD standard deviation, SE standard error