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Gilead Announces Presentation of Positive Phase III Data on,Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

he outcomes of this unique study, which was designed in concert with the Cystic Fibrosis Foundation, leading CF researchers and through a Special Protocol Assessment with the U.S. Food and Drug Administration," said A. Bruce Montgomery, MD, Senior Vice President, Head of Respiratory Therapeutics, Gilead Sciences. "These comprehensive findings provide valuable insights into the clinical profile of aztreonam lysine for inhalation. Data from additional studies in the AIR-CF Phase III clinical program will help to fully characterize the potential benefits and most effective use of this agent in people living with CF who have pulmonary P. aeruginosa."

Data from this analysis have not been reviewed by the U.S. Food and Drug Administration (FDA). Aztreonam lysine for inhalation is an investigational treatment and has not yet been determined safe or efficacious in humans.

About the AIR-CF Phase III Clinical Program

AIR-CF2 is one of three Phase III studies in the AIR-CF clinical program. The program, which also includes AIR-CF1 and AIR-CF3, is designed to determine the safety and efficacy of aztreonam lysine for inhalation for treatment of people with CF who have pulmonary P. aeruginosa.

AIR-CF1 is a double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course of aztreonam lysine for inhalation in people with CF who have pulmonary P. aeruginosa. The primary endpoint is the change at day 28 from baseline in respiratory symptoms as assessed by the CFQ-R questionnaire. This study has enrolled more than 150 patients who were randomized to receive 28 days of treatment with 75 mg aztreonam lysine for inhalation or volume-matched placebo administered TID by the eFlow Electronic Nebulizer.

AIR-CF3 is an open-label, multi-center study of patients who participated in the AIR-CF1 or AIR-CF2 studies. The primary objective of the study is to evaluate the safety of repeated exposure to aztreo
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