Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function

Summary

Double-blind, randomized, cross-over trial involving 20 participants with bronchiectasis. This trial will make an important contribution to therapeutic development in bronchiectasis by determining whether alpha-1 antitrypsin (AAT) therapy results in reduced airway inflammation and improves neutrophil function. Patients will be randomly assigned to receive Prolastin-C 120mg/kg (n=10 patients) by weekly intravenous infusions, Prolastin-C 180mg/kg (n=10 patients) by weekly intravenous infusions or placebo (0.9% saline) for a period of 4 weeks, followed by a 3-5 week washout period and a further 4 weeks during which patients will cross-over to receive the alternative therapy.

Timeline

Start

2022-11-01

Primary completion

2024-08-12

Completion

2024-08-12

Drugs

Indications