NCT01314716

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

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	AZLI	AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
DRUG	Placebo	Placebo to match AZLI administered via nebulizer three times daily

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-04-01
• Completion: 2013-07-01
• First posted: 2011-03-14
• Last updated: 2014-04-16
• Results posted: 2014-04-16

Locations

85 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom