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

临床试验：第三阶段 - 氨曲南赖氨酸吸入的多个疗程

• 批准号: 7716865
• 负责人: George Z Retsch-Bogart
• 金额: $ 0.08万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716865
• 关键词: Antibiotics; Aztreonam; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Dose; Drug Formulations; End Point; Enrollment; Evaluation; Exposure to; Funding; Grant; Institution; Label; Microbiology; Patients; Phase; Phase III Clinical Trials; Placebos; Research; Research Personnel; Resources; Safety; Source; Sputum; Treatment Protocols; United States National Institutes of Health; aerosolized; cystic fibrosis patients

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项3期、开放标签、后续研究，将在大约100个CF中心进行，研究对象是一种新型雾化抗生素氨曲南（AI）制剂。 最多400名参加过两项既往III期研究之一的CF患者将有资格入组本研究CP-AI-006。 每位患者将接受多达三个疗程的AI治疗。 患者将以与CP-AI-007中接受AI或安慰剂相同的给药方案（BID或TID）接受开放标签AI（75 mg）。 本研究的主要目的是评价CF患者重复暴露于AI的安全性。 次要目的包括评价重复暴露于AI对痰液微生物学和疾病相关终点的影响。