Following the recent success of a phase 3b clinical trial for Aztreonam in cystic fibrosis (CF) patients with Burkholderia infections, Gilead Sciences, Inc., a research-based biopharmaceutical company engaged in CF drug discovery and development, completed another phase 3 clinical trial to evaluate the safety of inhalable Aztreonam (AZLI) in children up to 12 years of age with CF and chronic Pseudomonas aeruginosa (PA) infection in the lower airways. A total of 61 participants from 25 study sites in the United States and Europe were given treatment.
The primary purpose of this open-label interventional study was the treatment of the opportunistic infection, consisting of three 28-day courses of AZLI three times daily, each followed by 28 days off the drug for a total treatment of 6 months.
Safety data was collected throughout the course of the treatment, and outcome measures included spirometry testing to evaluate pulmonary function and the revised Cystic Fibrosis Questionnaire (CFQ-R) to evaluate the quality of life of the patients, both increasing above baseline in treated subjects. Change in Pseudomonas Aeruginosa sputum density (colony-forming units per gram) was also evaluated, showing a decrease during the course of the treatment. Overall, researchers reported no safety issues, which means that AZLI could become a viable treatment for infection in CF patients in the near future.
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