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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