Inhaled A1AT in Adult Stable Bronchiectasis

• Status: Completed
• Trial end date: 1999-09-07
• Target enrollment: 0
• Participant gender: All

Summary

Aim: to investigate the influence of alpha1-antitrypsin (A1-AT) nebulization on levels of A1-AT in BAL and plasma in patients with stable bronchiectasis.

Method: single-blind placebo-controlled randomised clinical trial. 19 stable bronchiectasis patients with chronic bronchial infection and 10 control patients (without bronchiectasis) underwent a bronchoscopy in order to assess levels and inhibitory capacity of A1AT and neutrophilic elastase. Afterwards, the 19 bronchiectasis patients were randomly allocated to receive inhaled A1AT 250mg diluted in 10ml 0.9% saline solution once a day for a month (Group A, n: 10) or placebo (10ml 0.9% saline solution; group B, n: 9). A new BAL was performed in both groups (A and B) 24 hours after the end of treatment (1month) to re-analyze A1AT and NE.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Bayer; Instituto de Salud Carlos III; Sociedad Española de Neumología y Cirugía Torácica
• Treatments: Alpha 1-Antitrypsin

Criteria

Inclusion Criteria:

• Stable clinical conditions (no use of systemic antibiotic or steroid treatment in the last month)

• diagnosis of bronchiectasis bt CT scan

• chronic purulent or mucopurulent expectoration (daily sputum expectoration in the last 6 months or more)

Exclusion Criteria:

• Cystic fibrosis

• interstitial lung disease as cause of bronchiectasis