Arms60 mg/kg/wk vs 120 mg/kg/wk of intravenous alpha1-PI, vs placebo
Duration3 years
Primary EndpointLung loss via whole lung CT densitometry (15th percentile point) in each active arm vs placebo
Other Endpoints- Severe COPD exacerbations
 - Basal lung CT densitometry
 - Forced expiratory volume in 1 sec
 - Quality of life
Sample SizeTotal of 339 subjects (80% power at 0.025 level with an assumed 20% dropout)