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Table 1 Patient demographics and baseline characteristics (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

Total

 

(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)

(N = 378)

Mean (SD) age, years

57.7 (7.65)

54.5 (5.90)

54.4 (5.90)

56.9 (7.37)

59.6 (8.98)

56.4 (7.49)

59.4 (7.65)

54.6 (5.92)

59.0 (8.05)

Age <65 years, n (%)

120 (80.5)

89 (97.8)

90 (97.8)

124 (85.5)

40 (74.1)

126 (84.6)

42 (71.2)

92 (97.9)

278 (73.5)

Gender, n (%)

 Female

80 (53.7)

49 (53.8)

49 (53.3)

76 (52.4)

30 (55.6)

73 (49.0)

34 (57.6)

50 (53.2)

197 (52.1)

 Male

69 (46.3)

42 (46.2)

43 (46.7)

69 (47.6)

24 (44.4)

76 (51.0)

25 (42.4)

44 (46.8)

181 (47.9)

Race, n (%)

 White

131 (87.9)

81 (89.0)

83 (90.2)

132 (91.0)

51 (94.4)

135 (90.6)

49 (83.1)

84 (89.4)

339 (89.7)

 Black/African American

17 (11.4)

10 (11.0)

9 (9.8)

13 (9.0)

3 (5.6)

13 (8.7)

10 (16.9)

10 (10.6)

37 (9.8)

 American Indian/Alaskan Native

1 (0.7)

0

0

0

0

1 (0.7)

0

0

2 (0.5)

Post-bronchodilator FEV1, n (%)

  <50% predicted

60 (40.3)

34 (37.4)

34 (37.0)

59 (40.7)

28 (51.9)

62 (41.6)

25 (42.4)

35 (37.2)

NA

  ≥50% predicted

89 (59.7)

57 (62.6)

58 (63.0)

86 (59.3)

26 (48.1)

87 (58.4)

34 (57.6)

59 (62.8)

NA

  1. BID twice daily, FEV 1 forced expiratory volume in 1 s, NA not available, SD standard deviation