International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa

Phase 3 Completed 166 enrolled Gilead Sciences

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Timeline

Start: 2005-05
Primary completion: 2007-04
Completion: 2007-04

Outcome

Met primary endpoint

registry Placebo TID vs 75 mg AZLI TID; p = 0.0005; Mean Difference (Final Values) 9.71 NCT00112359 ↗

paper After 28 days of treatment, AZLI improved the mean CFQ-R respiratory score (9.7 points; p < 0.001), FEV(1) (10.3% predicted; p < 0.001), and sputum PA density (- 1.453 log(10) cfu/g; p < 0.001), compared with placebo. PMID 19420195 ↗

release “its Phase III AIR-CF1 met its primary efficacy endpoint” gilead.com ↗

Publications

Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest. 2009 May;135(5):1223-1232. doi: 10.1378/chest.08-1421.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aztreonam	Small molecule	75 mg	Inhaled