PHASE III - MULTIPLE COURSES OF AZTREONAM LYSINATE FOR INHALATION IN CF PATIENTS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项新的氨曲南(AI)雾化抗生素配方的第三阶段开放标签后续研究，将在大约100个CF中心进行。多达400名参加了之前两项第三阶段研究之一的CF患者将有资格参加这项名为CP-AI-006的研究。每个患者将接受最多三个疗程的人工智能治疗。患者将接受开放标签的AI(75 Mg)，剂量方案(BID或TID)与他们接受CP-AI-007中的AI或安慰剂相同。这项研究的主要目的是评估反复暴露于人工智能对慢性阻塞性肺疾病患者的安全性。次要目标包括评估反复暴露于人工智能对痰微生物和疾病相关终点的影响。

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.