Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), and with no history of two or more moderate or one or more severe exacerbations of COPD during the past year.
Conditions
Brief summary
FEV1 (L) post bronchodilator change from baseline at 104 weeks.
Detailed description
Change from baseline over 104 weeks of treatment in CT densitometry whole-lung 15th percentile lung density (PD15) at total lung capacity (TLC)., Change from baseline over 104 weeks of treatment in Post bronchodilator spirometry measures a. FEV1 % of predicted b. FEV1/FVC %, Exacerbations over 104 weeks of treatment; annual rate by severity and duration., Change from Baseline over 104 weeks of treatment in 6 minute walk test (6MWT).
Interventions
DRUGKamada-AAT for Inhalation
DRUGPlacebo for “Kamada-AAT for Inhalation”
Sponsors
Kamada Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 (L) post bronchodilator change from baseline at 104 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline over 104 weeks of treatment in CT densitometry whole-lung 15th percentile lung density (PD15) at total lung capacity (TLC)., Change from baseline over 104 weeks of treatment in Post bronchodilator spirometry measures a. FEV1 % of predicted b. FEV1/FVC %, Exacerbations over 104 weeks of treatment; annual rate by severity and duration., Change from Baseline over 104 weeks of treatment in 6 minute walk test (6MWT). | — |
Countries
Belgium, Finland, Ireland, Netherlands, Sweden
Outcome results
None listed