Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
The AIR-BX2 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.
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.