Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Inclusion Criteria:

• Male/Female 18 years or older with non-CF bronchiectasis

• Chronic sputum production on most days

• Positive sputum culture for gram-negative organisms

• Must have met lung function requirements

Exclusion Criteria:

• History of CF

• Hospitalized within 14 days prior to joining the study

• Previous exposure to AZLI

• Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study

• Must have met liver and kidney function requirements

• Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)

• Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment

• Other serious medical conditions.