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Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients with Pseudomonas Airway Infection.

Author(s): Trapnell BC, McColley SA, Kissner DG, Rolfe MW, Rosen JM, McKevitt M, Moorehead L, Montgomery AB, Geller DE

Affiliation(s): Divisions of Pulmonary Biology and Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.

Publication date & source: 2011-11-17, Am J Respir Crit Care Med., [Epub ahead of print]

RATIONALE: Fosfomycin/tobramycin for inhalation (FTI), a unique, broad-spectrum antibiotic combination, may have therapeutic potential for cystic fibrosis (CF) patients. OBJECTIVES: To evaluate safety and efficacy of FTI (160/40 mg or 80/20 mg), administered twice daily for 28 days versus placebo, in patients >/=18 years of age, with CF, chronic Pseudomonas aeruginosa (PA) airway infection, and FEV1 >/=25% and </=75% predicted. METHODS: This double-blind, placebo-controlled, multicenter study assessed whether FTI/placebo maintained FEV1% predicted improvements achieved following a 28-day, open label, run-in course of aztreonam for inhalation solution (AZLI). MEASUREMENTS AND MAIN RESULTS: 119 patients were randomized to FTI (160/40 mg: n=41; 80/20 mg: n=38) or placebo (n=40). Mean age was 32 years and mean FEV1 was 49% predicted at screening. Relative improvements in FEV1% predicted achieved by the AZLI run in were maintained in FTI groups compared to placebo (160/40 mg vs. placebo: 6.2% treatment difference favoring FTI, p=0.002 [primary endpoint]; 80/20 mg vs. placebo: 7.5% treatment difference favoring FTI, p<0.001). The treatment effect on mean PA sputum density was statistically significant for the FTI 80/20 mg group vs. placebo ( 1.04 log10 PA CFU/g sputum difference, favoring FTI; p=0.010). Adverse events, primarily cough, were consistent with CF disease. Respiratory events, including dyspnea and wheezing, were less common with FTI 80/20 mg than FTI 160/40. No clinically significant differences between groups were reported for laboratory values. CONCLUSIONS: FTI maintained the substantial improvements in FEV1% predicted achieved during the AZLI run-in and was well-tolerated. FTI is a promising antipseudomonal therapy for patients with CF.

Page last updated: 2011-12-09

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