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Table 1 Baseline demographics (mITT population)

From: A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

Parameter

GFF MDI

GP MDI 36 μg (N = 41)

Open-label tiotropium 18 μg (N = 58)

FF MDI

Placebo MDI (N = 52)

Open-label FFa DPI 12 μg (N = 55)

72/9.6 μg (N = 41)

36/9.6 μg (N = 43)

9.6 μg (N = 64)

7.2 μg (N = 64)

Age, years

 Mean (SD)

62.4 (9.4)

63.3 (8.3)

66.3 (6.1)

64.1 (7.9)

63.4 (8.9)

63.6 (8.9)

62.8 (9.6)

60.6 (9.0)

Gender, n (%)

 Male

25 (61.0)

24 (55.8)

23 (56.1)

34 (58.6)

34 (53.1)

36 (56.3)

29 (55.8)

34 (61.8)

Race, n (%)

 Black/African

0

0

0

0

3 (4.7)

3 (4.7)

3 (5.8)

3 (5.5)

 White

39 (95.1)

42 (97.7)

41 (100)

57 (98.3)

61 (95.3)

61 (95.3)

48 (92.3)

52 (94.5)

 Australia/New Zealand (indigenous)

2 (4.9)

1 (2.3)

0

1 (1.7)

0

0

1 (1.9)

0

Smoking status, n (%)

 Current

16 (39.0)

18 (41.9)

15 (36.6)

24 (41.4)

29 (45.3)

28 (43.8)

24 (46.2)

25 (45.5)

 Former

25 (61.0)

25 (58.1)

26 (63.4)

34 (58.6)

35 (54.7)

36 (56.3)

28 (53.8)

30 (54.5)

Duration of COPD, years

 Mean (SD)

7.6 (7.3)b

6.2 (5.4)c

7.8 (6.2)b

7.4 (6.7)d

8.6 (6.1)e

7.7 (4.4)f

8.3 (5.2)g

7.3 (4.3)h

Mean % predicted FEV1 (SD)

 Pre-bronchodilator

44.1 (13.9)b

46.8 (14.1)c

45.8 (13.5)b

44.9 (13.9)d

44.7 (12.6)e

43.9 (12.0)f

43.7 (11.6)g

44.0 (13.3)h

 Post-bronchodilator

50.6 (13.0)b

53.0 (13.1)c

51.5 (13.3)b

51.3 (13.4)d

51.4 (12.5)e

50.2 (12.6)f

51.1 (12.4)g

50.9 (12.9)h

Mean FEV1, L (SD)

 Pre-bronchodilator

1.33 (0.48)b

1.38 (0.47)c

1.30 (0.41)b

1.33 (0.47)d

1.29 (0.43)e

1.28 (0.40)f

1.30 (0.41)g

1.35 (0.46)h

 Post-bronchodilator

1.52 (0.47)b

1.56 (0.47)c

1.46 (0.40)b

1.51 (0.46)d

1.49 (0.46)e

1.47 (0.43)f

1.52 (0.47)g

1.56 (0.48)h

FEV1 bronchodilator reversibility, L (SD)i

 Mean (SD)

17.8 (16.3)b

16.3 (17.2)c

14.2 (14.5)b

17.1 (16.2)d

17.5 (14.7)e

15.9 (12.7)f

18.6 (12.9)g

18.5 (15.5)h

  1. aForadil® Aerolizer®; b n = 38; c n = 39; d n = 56; e n = 58; f n = 63; g n = 45; h n = 54; ipercentage change from pre-albuterol at 30 min post-albuterol for FEV1
  2. % = 100 × n/N, where n = number of patients in category and N = number of patients in the group
  3. Duration of COPD = (date of first dose of study treatment in the study – COPD onset date)/365.25
  4. Data from four sentinel patients were included in the mITT population in the analyses of demographic and baseline characteristics only
  5. COPD chronic obstructive pulmonary disease, DPI dry powder inhaler, FEV 1 forced expiratory volume in 1 s, FF formoterol fumarate, GFF glycopyrrolate/formoterol fumarate, GP glycopyrrolate, MDI metered dose inhaler, mITT modified intent-to-treat, SD standard deviation