AZTREONAM LYSINATE IN CF PATIENTS WITH PULMONARY PNEUMONIA AERUGINOSA

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase 3 study to assess the safety and efficacy of a 28-day treatment with Aztreonam Lysinate for inhalation (AI) in people with cystic fibrosis and positive Pa sputum/throat cultures aged greater than or equal to 6 with FEV1 between 25 and 75% predicted. It is a double-blind, randomized, placebo-controlled, multi-national, multi-center study. Subjects will receive 28 days of treatment with either 75 mg AI or placebo, taken 3 times a day using the eFlow nebulizer. The study consists of 5 outpatient visits - screening, treatment day 1, 14, 28 and 2-week follow-up visit. Only a few antibiotics are approved for inhaled therapy for Pa in CF. Aztreonam is approved for IV administration and is active against Pa. AI is a different salt form from the IV formulation to lessen the pulmonary irritation/bronchoreactivity.