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Table 3 Standardized change from baseline in FEV1 AUC0–12 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)
Standardized change from baseline in FEV1 AUC0–12 on Day 7
n 146 91 92 143 53 146 59 90
 Mean (SD), L −0.016 (0.187) 0.034 (0.178) 0.068 (0.181) 0.130 (0.174) 0.167 (0.200) 0.163 (0.201) 0.210 (0.143) 0.153 (0.224)
 LS mean (SE), L −0.016 (0.016) 0.036 (0.020) 0.071 (0.020) 0.129 (0.016) 0.162 (0.026) 0.163 (0.016) 0.205 (0.025) 0.156 (0.020)
 95% CI −0.047, 0.014 −0.003, 0.074 0.032, 0.109 0.098, 0.160 0.112, 0.213 0.133, 0.194 0.157, 0.253 0.117, 0.195
Placebo-adjusted change from baseline in FEV1 AUC0–12 on Day 7
 LS mean (SE), L 0.052 (0.025) 0.087 (0.025) 0.145 (0.022) 0.178 (0.030) 0.180 (0.022) 0.221 (0.029) 0.172 (0.025)
 95% CI 0.003, 0.101 0.038, 0.136 0.102, 0.188 0.120, 0.237 0.137, 0.223 0.164, 0.278 0.123, 0.221
  1. AUC area under the curve, BID twice daily, CI confidence interval, FEV 1 forced expiratory volume in 1 s, LS least squares, SD standard deviation, SE standard error