AIR-CF2 TRIAL WITH AZTREONAM LYSINATE FOR INHALATION IN CF PAT WITH P ARUGINOSA

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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, double blind, multi-center, randomized, placebo-controlled study to be conducted at approximately 50-60 centers in the United States. Subjects will receive 28 days of treatment with 75mg Aztreonam for Inhalation (AI) or volume-matched placebo administered twice or three times daily by the eFlow? Electronic Nebulizer. The total study period will be 126 days with nine-scheduled clinic visits. The current standard of care for CF lung disease is to prevent, delay or minimize the occurrence of pulmonary exacerbations (acute changes in respiratory signs and symptoms) using anti-pseudomonad therapy. The primary endpoint is time to need for IV or inhaled antibiotic therapy after initiation of treatment with AI/placebo. Patients will be given the option to enroll in the open-label study (CP-AI-006) at Visit 9 (final visit). Patients who terminate early from the study may enroll in CP-AI-006 on or after the date on which Visit 7 would have occurred according to the study schedule.