CLINICAL TRIAL: PHASE III - MULTIPLE COURSES OF AZTREONAM LYSINATE FOR INHALATIO

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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, open-label, follow-on study of a new aerosolized antibiotic formulation of aztreonam (AI) to be conducted at approximately 100 CF centers. Up to 400 CF patients who participated in one of two previous Phase III studies will be eligible to enroll in this study, CP-AI-006. Each patient will receive up to three courses of AI therapy. Patients will receive open-label AI (75mg) in the same dosing regimen (BID or TID) that they received AI or placebo in CP-AI-007. The primary objective of the study is to evaluate the safety of repeated exposure to AI in CF patients. Secondary objectives include evaluation of the effects of repeated exposure to AI on sputum microbiology and disease-related endpoints.