drugset / Trial / NCT00104520
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Timeline
- Start
- 2005-02
- Primary completion
- 2006-09
- Completion
- 2006-09
Outcome
Met primary endpoint
paper compared with placebo (AZLI, 92 d; placebo, 71 d; P = 0.007). PMID 18658109 ↗
release “AIR-CF2 data demonstrated that aztreonam lysine for inhalation significantly improved the time to need for inhaled or intravenous (IV) antibiotics” gilead.com ↗
release “met its primary efficacy endpoint, the time to need for inhaled or intravenous (IV) antibiotics” gilead.com ↗
Publications
- Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest. 2009 Jun;135(6):1610-1618. doi: 10.1378/chest.08-1190. Epub 2009 May 15.
- McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aztreonam | Small molecule | 75 mg | Inhaled |