Arms | 60 mg/kg/wk vs 120 mg/kg/wk of intravenous alpha1-PI, vs placebo |
Duration | 3 years |
Primary Endpoint | Lung 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 Size | Total of 339 subjects (80% power at 0.025 level with an assumed 20% dropout) |