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

第三阶段 - 服用赖氨酸氨曲南的多个疗程用于 CF 患者的吸入

• 批准号: 7625666
• 负责人: George Z Retsch-Bogart
• 金额: $ 0.13万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7625666
• 关键词: Antibiotics; Aztreonam; Breathing; 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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项针对新型氨曲南 (AI) 雾化抗生素制剂的开放标签后续研究，将在大约 100 个 CF 中心进行 3 期研究。 参加过之前两项 III 期研究之一的最多 400 名 CF 患者将有资格参加这项研究 CP-AI-006。 每位患者将接受最多三个疗程的人工智能治疗。 患者将按照与 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 (75mg)。 该研究的主要目的是评估 CF 患者反复接触 AI 的安全性。 次要目标包括评估反复接触人工智能对痰微生物学和疾病相关终点的影响。