AZTREONAM LYSINATE FOR INHALATION IN CYSTIC FIBROSIS PATIENTS WITH PULMONARY P1

赖氨酸氨曲南吸入治疗肺 P1 型囊性纤维化患者

• 批准号: 7374681
• 负责人: L T SPENCER
• 金额: $ 0.46万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374681
• 关键词: AZTREONAM; LYSINATE; INHALATION; CYSTIC; FIBROSIS

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. Corus Pharma, Inc. is developing Aztreonam Lysinate for Inhalation (AI, Cayston¿), a unique lyophilized formulation of the monobactam antibiotic Aztreonam for the treatment of CF patients with Pseudomonas aeruginosa (PA). This study will evaluate the safety and efficacy of 28 days of TID treatment with 75 mg of AI. The AI formulation was developed for administration using the eFlow¿ Electronic Nebulizer, reducing treatment time and potentially improving patient compliance. This is a Phase 3; multi-center, multinational, double-blind, randomized, placebo-controlled study conducted in approximately 18 CF centers in the United States, 4 CF centers in Canada and 10 CF centers in Australia. The total study period will be approximately 56 days with five scheduled clinic visits. The study schedule will include a variable (up to 14 days) screening period, a mid-treatment visit at Day 14, an End of Treatment visit at Day 28, and an End of Study follow-up visit 14 days after the last dose of the study drug. All patients will self-administer their first dose of AI or placebo in the clinic, via the eFlow

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。Corus Pharma, Inc.正在开发用于吸入的氨曲南赖氨酸（AI, Cayston¿），这是一种独特的单巴坦抗生素氨曲南冻干制剂，用于治疗患有铜绿假单胞菌（PA）的CF患者。本研究将评估75 mg AI治疗28天TID的安全性和有效性。AI配方是为使用eFlow¿电子雾化器管理而开发的，减少了治疗时间，并有可能提高患者的依从性。这是第三阶段；多中心、多国、双盲、随机、安慰剂对照研究在美国约18个CF中心、加拿大4个CF中心和澳大利亚10个CF中心进行。总研究期约为56天，包括5次预定的临床访问。研究计划将包括一个可变的（最多14天）筛选期，第14天的治疗中期访问，第28天的治疗结束访问，以及研究药物最后一次剂量后14天的研究结束随访。所有患者将在诊所通过eFlow自行服用第一剂AI或安慰剂