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Table 1 Patient demographics and characteristics (ITT/safety population)

From: A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD

Parameter

GP MDI 28.8 μg BID, N = 49

GP MDI 14.4 μg BID, N = 49

GP MDI 7.2 μg BID, N = 49

GP MDI 3.6 μg BID, N = 45

Placebo MDI BID, N = 48

Ipratropium MDI 34 μg QID, N = 48

All patients, N = 103

Mean age, years (SD)

61.6 (7.9)

63.3 (7.9)

60.3 (8.2)

60.6 (8.8)

61.5 (7.8)

61.3 (9.0)

61.2 (8.2)

Gender, % male

49.0

55.1

59.2

48.9

60.4

43.8

53.4

Race, % Black or African/Caucasian/Other

6.1/85.7/8.2

8.2/87.8/4.1

8.2/87.8/4.1

6.7/88.9/4.4

8.3/87.5/4.2

6.3/87.5/6.3

6.8/88.3/4.9

Mean BMI, kg/m2 (SD)

30.1 (6.6)

27.5 (7.2)

29.0 (8.9)

29.0 (8.1)

28.2 (7.4)

29.2 (8.1)

28.8 (7.6)

Smoking status, % current smokers

63.3

59.2

67.3

71.1

64.6

66.7

67.0

Mean smoking history, pack-years (SD)

63.4 (25.8)

63.0 (28.2)

61.8 (27.5)

72.3 (28.0)

67.8 (30.1)

61.3 (25.9)

64.2 (27.4)

Mean duration of COPD at baseline, years (SD)

7.8 (4.8)

8.6 (6.8)

8.8 (5.5)

7.8 (5.8)

8.7 (6.5)

7.8 (5.5)

8.1 (5.9)

FEV1 a, N

45

46

44

41

46

45

91

 Mean screening FEV1 pre-bronchodilator, % predicted (SD)

49.9 (13.6)

47.0 (13.0)

48.3 (12.6)

47.4 (12.1)

47.8 (13.2)

48.6 (12.7)

48.2 (12.9)

 Mean screening FEV1 pre-bronchodilator, L (SD)

1.464 (0.546)

1.379 (0.523)

1.471 (0.572)

1.407 (0.565)

1.474 (0.553)

1.406 (0.553)

1.440 (0.551)

 Mean screening FEV1 post-bronchodilator, % predicted (SD)

57.8 (12.7)

55.0 (13.8)

56.2 (12.6)

56.1 (12.4)

55.3 (12.9)

57.3 (13.0)

56.3 (12.9)

 Mean screening FEV1 post-bronchodilator, L (SD)

1.692 (0.536)

1.614 (0.584)

1.708 (0.598)

1.658 (0.613)

1.696 (0.566)

1.663 (0.611)

1.680 (0.586)

 Mean baseline FEV1, % predicted (SD)

47.1 (14.1)

43.7 (13.3)

46.5 (12.3)

46.1 (12.4)

45.4 (14.0)

46.4 (12.3)

45.9 (13.2)

 Mean baseline FEV1, L (SD)

1.381 (0.548)

1.285 (0.512)

1.430 (0.570)

1.372 (0.584)

1.404 (0.584)

1.346 (0.531)

1.376 (0.556)

 Reversibilitya,b, N

45

46

44

41

46

45

91

 Mean reversibility post-bronchodilator for FEV1, % (SD)

18.3 (13.7)

18.5 (13.2)

18.1 (11.1)

19.9 (13.3)

17.4 (11.5)

19.8 (14.1)

18.6 (12.9)

 Reversible, n (%)

28 (62.2)

30 (65.2)

28 (63.6)

28 (68.3)

31 (67.4)

28 (62.2)

59 (64.8)

  1. amITT population
  2. bReversibility was defined as > 200 mL improvement in FEV1 post-bronchodilator administration compared to pre-bronchodilator value and/or > 12% and > 150 mL improvement in FEV1 post-bronchodilator administration compared to pre-bronchodilator value
  3. BID Twice daily, BMI Body mass index, COPD Chronic obstructive pulmonary disease, FEV 1 Forced expiratory volume in 1 s, GP Glycopyrronium, ITT Intent-to-treat, mITT Modified intent-to-treat, MDI Metered dose inhaler, QID Four times daily, SD Standard deviation,
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Respiratory Research

ISSN: 1465-993X

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