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Phase III results for aztreonam lysine in cystic fibrosis


Gilead Sciences, Inc recently announced results from an interim analysis of 12-month data from its open-label, phase III AIR-CF3 (006) study of aztreonam lysine for inhalation, an investigational therapy in development for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa).

Patients receiving aztreonam lysine three times daily experienced improvements in FEV1 after completion of six courses of treatment, with a mean change from baseline of 5.2 percent (SD=18.4; n=70). These patients also experienced a mean improvement from baseline of 4.2 points in the CFQ-R Respiratory Symptoms scale (SD=20.2; n=70) after completion of six courses of treatment.

Mean values for the three times daily group did not drop below baseline FEV1 percent predicted or CFQ-R Respiratory Symptoms scores during any on-treatment or off-treatment interval over the first 12 months of treatment.

Over six courses of treatment, aztreonam lysine three times daily was also associated with reductions in P. aeruginosa colony forming units (a measure of the amount of bacteria present in the lungs), with a mean change from baseline of -0.42 (log reduction, SD=2.11; n=52) in the three times daily group.

The incidence of hospitalisation for all courses pooled over a period of up to 18 months (n=274 patients) was 41.2 percent (n=113) and the median time to hospitalisation was 390 days.

Aztreonam lysine was well tolerated with a safety profile consistent with the expected symptoms of a patient with underlying cystic fibrosis disease. The most common adverse events were cough, nasal congestion, pyrexia, wheezing, pharyngolaryngeal pain, chest discomfort and rhinorrhea.

These data were presented by Christopher M Oermann, MD, Associate Professor of Pediatrics, Director, Pediatric Pulmonary Fellowship Training Program, Baylor College of Medicine, at the 31st Annual European Cystic Fibrosis Conference which took place last week in Prague, Czech Republic.

Gilead Sciences

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