AZTREONAM LYSINATE IN CF PATIENTS WITH PULMONARY PNEUMONIA AERUGINOSA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项3期研究，旨在评估在囊性纤维化患者和年龄大于或等于6岁的PA痰/咽培养阳性患者中使用氨曲南赖氨酸盐吸入(AI)治疗28天的安全性和有效性，预计FEV1在25%至75%之间。这是一项双盲、随机、安慰剂对照、多国家、多中心的研究。受试者将接受为期28天的治疗，使用75 mg人工智能或安慰剂，每天3次，使用eFlow雾化器。研究包括5次门诊筛查、治疗第1天、第14天、第28天和2周的随访。只有少数抗生素被批准用于吸入性治疗CF中的PA。氨曲南被批准用于静脉给药，并有效对抗PA。AI是一种不同于IV配方的盐形式，以减轻肺部刺激/支气管反应性。

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 study to assess the safety and efficacy of a 28-day treatment with Aztreonam Lysinate for inhalation (AI) in people with cystic fibrosis and positive Pa sputum/throat cultures aged greater than or equal to 6 with FEV1 between 25 and 75% predicted. It is a double-blind, randomized, placebo-controlled, multi-national, multi-center study. Subjects will receive 28 days of treatment with either 75 mg AI or placebo, taken 3 times a day using the eFlow nebulizer. The study consists of 5 outpatient visits - screening, treatment day 1, 14, 28 and 2-week follow-up visit. Only a few antibiotics are approved for inhaled therapy for Pa in CF. Aztreonam is approved for IV administration and is active against Pa. AI is a different salt form from the IV formulation to lessen the pulmonary irritation/bronchoreactivity.