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Table 4 Changes in PD15 (g/L) in basal, middle and apical regions of the lung in patients treated with Prolastin versus placebo (mITT population)

From: Exploring the optimum approach to the use of CT densitometry in a randomised placebo-controlled study of augmentation therapy in alpha 1-antitrypsin deficiency

Basal region Prolastin
(n = 36)
Placebo
(n = 35)
Change from baseline to last CT scan (mean ± SD) -2.336 ± 4.362 -3.760 ± 4.284
Change from baseline to last CT scan (LS mean [SE]) -2.118 (0.587)
0.0006a
-3.840 (0.604)
< 0.0001a
Estimated treatment difference between LS mean changes from baseline (95% CI) 1.722 (0.082, 3.362)
p value for treatment differenceb 0.040
Middle region Prolastin
(n = 36)
Placebo
(n = 35)
Change from baseline to last CT scan (mean ± SD) -2.845 ± 5.796 -3.838 ± 4.696
Change from baseline to last CT scan (LS mean [SE]) -2.504 (0.655)
0.0003a
-3.816 (0.673)
< 0.0001a
Estimated treatment difference between LS mean changes from baseline (95% CI) 1.312
(-0.511, 3.135)
p value for treatment differenceb 0.155
Apical region Prolastin
(n = 36)
Placebo
(n = 35)
Change from baseline to last CT scan (mean ± SD) -3.503 ± 7.433 -3.911 ± 5.939
Change from baseline to last CT scan (LS mean [SE]) -3.217 (0.990)
0.0018a
-3.799 (1.001)
0.0004a
Estimated treatment difference between LS mean changes from baseline (95% CI) 0.581
(-2.159, 3.322)
p value for treatment differenceb 0.673
  1. PD15, 15th percentile lung density; CT, computed tomography; SD, standard deviation; LS mean, least squares mean; SE, standard error; 95% CI, 95% confidence interval. ap values are for the comparison of change from baseline to last CT scan versus no change from baseline within the individual treatment groups. bProlastin treatment minus placebo (LS mean change).