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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