Changes in total lung capacity(TLC)-adjusted and statistically adjusted 15th percentile lung density (PD15) using end-point analysis#
| Method 3 (Physiological)¶ | Method 4 (Statistical)+ | |||
| Prolastin® | Placebo | Prolastin® | Placebo | |
| Subjects n | 36 | 35 | 36 | 35 |
| Change from baseline to last CT scan g·L−1 | ||||
| Mean±sd | -3.387±4.621 | -4.822±3.813 | -2.895±4.739 | -4.124±4.147 |
| LS mean±se | -3.202±0.657 | -4.798±0.671 | -2.645±0.526 | -4.117±0.539 |
| Estimated treatment difference between changes from baseline g·L−1 | 1.596 (-0.220–3.412) | 1.472 (0.009–2.935) | ||
| p-value for treatment difference§ | 0.084 | 0.049 | ||
Data are presented as value (95% confidence interval), unless otherwise stated. CT: computed tomography; LS: least squares. #: modified intent-to-treat population; ¶: change from baseline to the last CT scan measurement in TLC-adjusted PD15 as the dependent variable; treatment and centre as fixed factors; and baseline measurement as covariate. +: change from baseline to the last CT scan measurement in PD15 as the dependent variable; treatment and centre as fixed factors; and change in logarithm of CT-measured total lung volume and baseline measurement as covariates. §: Prolastin® treatment minus placebo.