AZTREONAM LYSINATE FOR INHALATION IN CYSTIC FIBROSIS PATIENTS WITH PULMONARY P1

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。 Corus Pharma，Inc.正在开发吸入用氨曲南赖氨酸盐（AI，Cayston），这是一种独特的单环内酰胺类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。本研究将评价75 mg AI TID治疗28天的安全性和疗效。开发的AI制剂用于使用eFlow电子雾化器给药，减少了治疗时间，并可能提高患者依从性。 这是第三阶段;一项在美国约18家CF中心、加拿大4家CF中心和澳大利亚10家CF中心进行的多中心、多国、双盲、随机、安慰剂对照研究。 总研究期约为56天，计划进行5次门诊访视。 研究时间表将包括可变（长达14天）筛选期、第14天的治疗中期访视、第28天的治疗结束访视和研究药物末次给药后14天的研究结束随访访视。所有患者将通过eFlow在诊所自行给药AI或安慰剂的第一剂

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