drugset / Trial / NCT00499837
Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways. The purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in CF patients.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 80 mg/kg | Other |