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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.