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Table 2 Patient baseline demographic characteristics*

From: Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed tomography densitometry

 

Danish-Dutch trial

EXACTLE trial

Combined data

 

AAT

(n = 27)

Placebo

(n = 27)

AAT

(n = 38)

Placebo

(n = 39)

AAT

(n = 60)

Placebo

(n = 59)

p value

Age (y)

48.0 ± 7.99

47.5 ± 7.29

54.7 ± 8.4

55.3 ± 9.8

51.6 ± 9.03

51.8 ± 9.73

0.808

Sex (n) male/female

18/9

16/11

25/13

16/23

38/22

29/30

0.093

Smoking status (n, ex/never)

27/0

27/0

34/4

35/4

56/4

56/3

0.748

Body mass index (kg•m2)

23.3 ± 3.15

24.4 ± 2.70

24.3 ± 3.3

24.3 ± 3.5

24.0 ± 3.3

24.5 ± 3.2

0.355

FEV1 (L), median

1.63 ± 0.49

1.63

1.72 ± 0.53

1.61

1.44 ± 0.60

1.14

1.35 ± 0.62

1.14

1.55 ± 0.56

1.47

1.48 ± 0.63

1.38

0.553

FEV1% predicted, median

47.3 ± 11.4

48.6

51.2 ± 14.5

49.0

46.3 ± 19.6

41.1

46.6 ± 21.0

39.5

48.0 ± 16.4

47.2

47.9 ± 18.6

43.1

0.949

 

Danish-Dutch trial

EXACTLE trial

Combined data

 

AAT (n = 27)

Placebo (n = 27)

AAT (n = 38)

Placebo (n = 39)

AAT (n = 60)

Placebo (n = 59)

p value

VC % predicted

114 ± 14.7

117 ± 16.4

94 ± 21.8

98 ± 23.2

103.1 ± 21.8

104.7 ± 23.9

0.789

DLCO% predicted Median

59.7 ± 16.0

57.0

60.1 ± 16.3

65.0

50.7 ± 19.5

47.6

52.2 ± 15.2

50.1

56.3 ± 17.3

56.1

55.7 ± 15.9

56.0

0.797

KCO % predicted

62.2 ± 17.62

59.9 ± 16.9

55.3 ± 21.0

56.5 ± 14.8

60.0 ± 18.9

58.6 ± 15.5

0.619

Unadjusted PD15 (g•L-1)

71.41 ± 20.87

75.56 ± 25.53

47.98 ± 19.07

45.48 ± 16.95

58.88 ± 23.03

59.79 ± 25.83

0.844

TLC-adjusted PD15 (g•L-1)

59.9 ± 11.03

62.98 ± 13.49

54.6 ± 17.4

53.9 ± 16.0

57.1 ± 15.2

58.2 ± 15.7

0.691

Lung volume (L)

5.71 ± 1.27

5.52 ± 1.34

7.46 ± 1.60

7.27 ± 1.78

6.61 ± 1.67

6.35 ± 1.69

0.300

  1. * Values are mean ± SD unless otherwise indicated.
  2. TLC-adjusted PD15: CT lung density multiplied by CT-measured total lung volume and divided by the individual patient's predicted TLC.
  3. For the CT densitometric analyses, the modified ITT population was used.
  4. The combined analysis was based on the modified ITT population and did not include the data for 6 subjects who participated in EXACTLE, but who had also participated in the earlier Danish-Dutch study.
  5. AAT: alpha-1 antitrypsin; DLco: diffusion capacity of the lung for carbon monoxide; EXACTLE: Exacerbations and Computed Tomography scan as Lung Endpoints; Kco: carbon monoxide transfer co-efficient; PD15: 15th percentile lung density; TLC: total lung capacity; VC: vital capacity.