Published ahead of print on July 24, 2008, doi:10.1164/rccm.200712-1804OC
© 2008 American Thoracic Society doi: 10.1164/rccm.200712-1804OC
Inhaled Aztreonam Lysine for Chronic Airway Pseudomonas aeruginosa in Cystic Fibrosis1 Ohio State University, Columbus, Ohio; 2 University of Miami, Coral Gables, Florida; 3 Baylor College of Medicine, Houston, Texas; 4 Children's Hospital and Regional Medical Center, Seattle, Washington; 5 University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and 6 Gilead Sciences, Inc., Seattle, Washington Correspondence and requests for reprints should be addressed to Karen S. McCoy, M.D., Associate Professor of Pediatrics, Ohio State University, Nationwide Children's Hospital, Columbus, OH 43205. E-mail: karen.mccoy{at}nationwidechildrens.org Rationale: The effectiveness and safety of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF) on maintenance treatment for Pseudomonas aeruginosa (PA) airway infection was evaluated in this randomized, double-blind, placebo-controlled study. Objectives: To evaluate the safety and efficacy of inhaled aztreonam lysine in controlling PA infection in patients with CF.
Methods: After randomization and a 28-day course of tobramycin inhalation solution (TIS), patients (n = 211; Measurements and Main Results: AZLI treatment increased median time to need for additional antipseudomonal antibiotics for symptoms of pulmonary exacerbation by 21 days, compared with placebo (AZLI, 92 d; placebo, 71 d; P = 0.007). AZLI improved mean CFQ-R respiratory scores (5.01 points, P = 0.02), FEV1 (6.3%, P = 0.001), and sputum PA density (–0.66 log10 cfu/g, P = 0.006) compared with placebo; no AZLI dose–response was observed. Adverse events reported for AZLI and placebo were comparable and consistent with CF lung disease. Susceptibility of PA to aztreonam at baseline and end of therapy were similar. Conclusions: AZLI was effective in patients with CF using frequent TIS therapy. AZLI delayed time to need for inhaled or intravenous antipseudomonal antibiotics, improved respiratory symptoms and pulmonary function, and was well tolerated. Clinical trial registered with www.clinicaltrials.gov (NCT 00104520).
Key Words: cystic fibrosis • Pseudomonas • aztreonam • inhaled antibiotics • patient-reported outcomes • respiratory symptoms
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6 yr; 
75% predicted values) were treated with 75 mg AZLI or placebo, twice or three times daily for 28 days, then monitored for 56 days. The primary efficacy endpoint was time to need for additional inhaled or intravenous antipseudomonal antibiotics. Secondary endpoints included changes in respiratory symptoms (CF Questionnaire-Revised [CFQ-R] Respiratory Scale), pulmonary function (FEV1), and sputum PA density. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored. 
