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 |