Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed tomography densitometry

Table 3 Changes in unadjusted 15^th 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.

ISSN: 1465-993X