drugset / Trial / NCT00712166

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

NCT00712166

Phase 3 Completed 160 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), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.

Timeline

Start
2008-05
Primary completion
2009-06
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Aztreonam Small molecule 75 mg Inhaled