OPEN-LABEL AZTREONAM LYSINATE FOR INHALATION IN CYSTIC FIBROSIS

点击翻译按钮获取中文摘要

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 study is an open-label, muticenter study in patients who participated in one of two previous Phase 3 AI studies (CP-AI-004 or CP-AI-005). Patients will receive treatment with 75 mg Aztreonam Lysinate for Inhalation (AI) in the same regiment (twice daily [BID] or three times daily [TID] to which they were assigned in CP-AI-004/005. Up to 370 patients will be enrolled from up to 70 CF centers throughout the United States. This study will last approximately 6 months for each patient. Patients will receive up to three 28-day courses of AI, each of which will be followed by a 28-day off drug period. The first two AI courses are mandatory; the third course will be at the physician's discretion. During the study, patient may be treated as needed with any antipseudomonal antibiotics (oral, IV or inhaled) with the exception of IV Aztreonam. The primary objective of the study is to evaluate the safety of repeated exposure to Aztreonam Lysinate for Inhalation (AI) in cystic fibrosis (CF) patients. Secondary objective include evaluation of the effects of repeated exposure to AI in microbiology and disease-related endpoints. Safety will be evaluated by monitoring adverse events, airway reactivity, vital signs, and serum chemistry and hematology. Microbiology will be evaluated by PA CFU density in sputum, disappearance or appearance of other bacterial pathogens and fungal pathogens, and minimum inhibitory concentration (MIC) of Aztreonam for PA. Other endpoints will also be evaluated to include FEV1, FVC, and FEF 25-75, clinical symptoms as assessed by the CF Questionnaire-Revised (CFQ-R), hospitalizations, body weight, missed school or work days due to CF illness, and time to intravenous antibiotics.