Table 3.
Changes in unadjusted 15th percentile lung density (g•L-1) using endpoint analysis
| Danish-Dutch trial | EXACTLE trial | Combined data | ||||
|---|---|---|---|---|---|---|
|
Statistic |
AAT (n = 27) |
Placebo (n = 27) |
AAT (n = 36) |
Placebo (n = 35) |
AAT (n = 60) |
Placebo (n = 59) |
| Change from baseline to last CT scan, LS mean |
-6.409 |
-9.564 |
-2.645 |
-4.117 |
-4.082 |
-6.379 |
| Estimated treatment difference between changes from baseline, 95% CI† |
3.155 (0.008-6.301) |
1.472 (0.009-2.935) |
2.297 (0.669-3.926) |
|||
| p value for treatment difference | 0.049 | 0.049 | 0.006 |
For the CT densitometric analyses, the modified ITT population was used. 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 their data included in the earlier Danish-Dutch study.
†AAT treatment minus placebo.
AAT: alpha-1 antitrypsin; CT: computed tomography; EXACTLE: Exacerbations and Computed Tomography scan as Lung Endpoints; LS: least squares.