AIR-CF2 TRIAL WITH AZTREONAM LYSINATE FOR INHALATION IN CF PAT WITH P ARUGINOSA

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项III期、双盲、多中心、随机化、安慰剂对照研究，将在美国约50-60个中心进行。受试者将通过eFlow？接受75 mg氨曲南吸入（AI）或容量匹配安慰剂治疗28天，每日两次或三次电子雾化器。总研究期为126天，计划进行9次门诊访视。CF肺病的当前标准治疗是使用抗假单胞菌治疗预防、延迟或最小化肺部急性加重（呼吸体征和症状的急性变化）的发生。主要终点是开始AI/安慰剂治疗后至需要IV或吸入抗生素治疗的时间。患者可选择在访视9（最终访视）时入组开放标签研究（CP-AI-006）。提前终止研究的患者可在根据研究时间表应进行访视7的日期或之后入组CP-AI-006。

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, double blind, multi-center, randomized, placebo-controlled study to be conducted at approximately 50-60 centers in the United States. Subjects will receive 28 days of treatment with 75mg Aztreonam for Inhalation (AI) or volume-matched placebo administered twice or three times daily by the eFlow? Electronic Nebulizer. The total study period will be 126 days with nine-scheduled clinic visits. The current standard of care for CF lung disease is to prevent, delay or minimize the occurrence of pulmonary exacerbations (acute changes in respiratory signs and symptoms) using anti-pseudomonad therapy. The primary endpoint is time to need for IV or inhaled antibiotic therapy after initiation of treatment with AI/placebo. Patients will be given the option to enroll in the open-label study (CP-AI-006) at Visit 9 (final visit). Patients who terminate early from the study may enroll in CP-AI-006 on or after the date on which Visit 7 would have occurred according to the study schedule.