Table 1.
Patient characteristics at baseline (ITT population)
| Prolastin (n = 38) |
Placebo (n = 39) |
p value | |
| Age (years, mean ± SD) | 54.7 ± 8.4 | 55.3 ± 9.8 | 0.749 |
| Gender (n, male/female) | 25/13 | 16/23 | 0.021 |
| FEV1% predicted (mean ± SD) | 46.3 ± 19.6 | 46.6 ± 21.0 | 0.873 |
| PD15 (g/L, mean ± SD)a | |||
| Whole lung | 47.98 ± 19.07 | 45.48 ± 16.95 | 0.288 |
| Apical region | 63.36 ± 24.96 | 62.96 ± 19.77 | 0.625 |
| Middle region | 51.48 ± 18.35 | 48.35 ± 18.40 | 0.232 |
| Basal region | 38.61 ± 18.90 | 34.94 ± 15.44 | 0.182 |
| MLD (g/L, mean ± SD)a | 131.57 ± 21.99 | 131.68 ± 18.89 | 0.719 |
| VI-910 (%, mean ± SD)a | 44.43 ± 13.66 | 45.11 ± 12.02 | 0.509 |
| VI-950 (%, mean ± SD)a | 18.66 ± 10.97 | 19.77 ± 9.81 | 0.435 |
| Lung weight (g, mean ± SD)a | 956.40 ± 140.64 | 946.09 ± 224.12 | 0.750 |
| Lung volume (L, mean ± SD)a | 7.46 ± 1.60 | 7.27 ± 1.78 | 0.557 |
SD, standard deviation; FEV1, forced expiratory volume in 1 second; PD15, 15th percentile lung density; MLD, mean lung density; VI-910, voxel index at a threshold of -910 (measured in %); VI-950, voxel index at a threshold of -950 (measured in %). aFor the CT densitometric analyses, the mITT population was used (n = 36, Prolastin; n = 35, placebo).