drugset
drugset / Trial / NCT03383939

Inhaled A1AT in Adult Stable Bronchiectasis

NCT03383939 ↗

Completed 20 enrolled Hospital Universitari Vall d'Hebron Research Institute Bayer · collabInstituto de Salud Carlos III · collabSociedad Española de Neumología y Cirugía Torácica · collab
RandomizedParallel-groupSingle-blindSupportive care

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.

Timeline

Start
1996-06-01
Primary completion
1999-09-07
Completion
1999-09-07

Drugs

EvaluationDrugModalityDoseRoute
Subject group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine Vaccine 250 mg Inhaled

Indications

bronchiectasis