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Table 1 Baseline demographics and clinical characteristics (safety population)

From: Bone and ocular safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a 52-week randomized study

 

BGF MDI

320/18/9.6 μg

(N = 194)

BFF MDI

320/9.6 μg

(N = 88)

GFF MDI

18/9.6 μg

(N = 174)

Age, years (mean [SD])

62.6 (7.9)

64.0 (7.2)

62.4 (7.8)

Male, n (%)

102 (52.6)

53 (60.2)

87 (50.0)

Race, n (%)

 White

179 (92.3)

79 (89.8)

156 (89.7)

 Black

13 (6.7)

9 (10.2)

17 (9.8)

 Other

2 (1.0)

0

1 (0.6)

Ethnicity, n (%)

 Hispanic or Latino

9 (4.6)

6 (6.8)

5 (2.9)

 Not Hispanic or Latino

185 (95.4)

82 (93.2)

169 (97.1)

Body mass index, kg·m−2 (mean [SD])

29.0 (7.4)

29.0 (5.8)

29.0 (6.5)

Current smoker, n (%)

101 (52.1)

42 (47.7)

95 (54.6)

Number of pack-years smoked# (median [range])

45.0 (11.2–256.0)

47.3 (14.3–134.0)

50.0 (10.0–171.0)

COPD severity, n (%)

 Moderate

95 (49.0)

45 (51.1)

91 (52.3)

 Severe

86 (44.3)

37 (42.0)

65 (37.4)

 Very severe

13 (6.7)

6 (6.8)

18 (10.3)

COPD duration, years (mean [SD])

8.6 (6.7)

9.6 (6.3)

7.7 (5.3)

Moderate/severe COPD exacerbations in the past 12 months, n (%)

 0

152 (78.4)

67 (76.1)

129 (74.1)

 1

33 (17.0)

18 (20.5)

34 (19.5)

  ≥2

9 (4.6)

3 (3.4)

11 (6.3)

Eosinophil count, cells·mm− 3 (median, [range])

180 (10–655)

190 (15–505)

185 (40–2490)

 <150 cells·mm− 3, n (%)

68 (35.1)

32 (36.4)

54 (31.0)

 ≥150 cells·mm−3, n (%)

126 (64.9)

56 (63.6)

120 (69.0)

Use of ICS at screening, n (%)

152 (78.4)

73 (83.0)

127 (73.0)

CAT total score (mean [SD])

21.2 (6.4)n = 192

22.3 (6.7) n = 86

20.4 (6.3) n = 172

EXACT total score (mean [SD])

35.2 (10.8)n = 194

35.7 (10.4) n = 86

34.6 (10.6) n = 174

Rescue medication use, puffs·day− 1 (median [range])

1.9 (0.0–12.0)n = 194

2.4 (0.0–17.7) n = 86

2.0 (0.0–18.2) n = 174

  1. BFF Budesonide/formoterol fumarate, BGF Budesonide/glycopyrrolate/formoterol fumarate, CAT COPD Assessment Test, COPD Chronic obstructive pulmonary disease, EXACT Exacerbations of Chronic Pulmonary Disease Tool, GFF Glycopyrrolate/formoterol fumarate, ICS Inhaled corticosteroid, MDI Metered dose inhaler, mITT Modified intent-to-treat, SD Standard deviation. #: number of pack-years smoked = (number of cigarettes each day/20) × number of years smoked, : mITT population