Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

Phase 3 Completed 274 enrolled Gilead Sciences Chiltern International Inc. · collab ClinPhone, Inc. · collab Covance · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.

Timeline

Start: 2008-08
Primary completion: 2010-05
Completion: 2010-11

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); AZLI (75 mg TID) vs TIS (300 mg BID); p = 0.0001; NCT00757237 ↗

registry analysis (superiority or other test); AZLI (75 mg TID) vs TIS (300 mg BID); p = 0.0023; NCT00757237 ↗

paper Mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. PMID 22985692 ↗

Publications

Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aztreonam	Small molecule	75 mg	Inhaled
Comparator	Tobramycin	Unknown	300 mg	Inhaled