AZTREONAM LYSINATE FOR INHALATION IN CYSTIC FIBROSIS PATIENTS WITH PULMONARY P1

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。Corus Pharma，Inc.正在开发吸入型氨曲南来辛酸盐(AI，Cayston？)，这是一种用于治疗患有铜绿假单胞菌(PA)的CF患者的单杆菌抗生素氨曲南的独特冻干制剂。本研究将评估75 mg AI治疗28天TID的安全性和有效性。人工智能配方是为使用eFlow电子雾化器进行管理而开发的，可以减少治疗时间并潜在地提高患者的依从性。这是一项第三阶段的多中心、多国、双盲、随机、安慰剂对照研究，在美国的大约18个CF中心、加拿大的4个CF中心和澳大利亚的10个CF中心进行。总的研究期约为56天，有5次预定的门诊就诊。研究计划将包括一个可变的(最多14天)筛查期，第14天的治疗中期访问，第28天的治疗访问结束，以及最后一剂研究药物后14天的研究跟踪访问结束。所有患者将通过eFlow在临床上自我给予第一剂AI或安慰剂

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