Gilead Sciences announced that its Phase III AIR-CF1 study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint of change at 28 days.
The company stated that the results were assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome tool used to measure health-related quality of life for people with cystic fibrosis. Data from the 164-patient, double-blinded, randomised study demonstrated a significant improvement in the CFQ-R, following a 28-day treatment course with 75mg aztreonam lysine for inhalation or volume-matched placebo administered three times daily by the PARI eFlow Electronic Nebulizer, Gilead stated.
Gilead added that aztreonam lysine-treated patients also experienced significant improvements at day 28 in respiratory function, as measured by relative improvement of FEV1, with a treatment difference in mean change from baseline of 10.3% versus placebo. The most common adverse events in this study were cough, productive cough, nasal congestion, sore throat and dyspnea, or shortness of breath.
The US firm says that it plans to seek marketing approval from the Food and Drug Administration for aztreonam lysine in the second half of 2007, having reported data from another late-stage trial earlier this year which found that the compound reduced the need for inhaled or intravenous antibiotics.