TRIAL EVALUATING AZTREONAM LYSINATE FOR INHALATION IN CF PTS WITH AIR-CF1

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Patients with cystic fibrosis (CF) often have chronic lung infections. Long-term antibiotic treatment makes the development of bacterial resistance to antibiotics a significant concern for CF doctors. The development of new antibiotics or formulations is very important for the treatment of patients with CF. Aztreonam is an approved antibiotic with antibacterial activity similar to that of aminoglycoside antibiotics. When given intravenously, it has been shown to be safe and efficacious for treatment of CF lung infections. A new formulation of aztreonam, Aztreonam Lysinate for Inhalation (AI), has been developed as an option for treatment of pulmonary infections. Although aztreonam's range of activity is similar to that of tobramycin and gentamicin, aztreonam kills bacteria through a different mechanism than aminoglycosides. Thus, aztreonam should not contribute to the emergence of aminoglycoside-resistant bacteria. A phase I study and phase II study of AI in stable patients with CF have been completed with a total enrollment of approximately 100 patients. AI appeared to be safe and well-tolerated, resulted in a significant killing of Pseudomonas bacteria, and improved lung function after 7 and 14 days of treatment with the 75 mg dose of AI nebulized two times a day for 14 days. The results also suggested that the use of bronchodilators may improve AI deposition into the lungs. This phase III, double-blind, multicenter, multinational, randomized, placebo-controlled clinical trial evaluated the safety and efficacy of a 28-day treatment with AI in CF patients with lung disease due to Pseudomonas aeruginosa infection.