AZTREONAM LYSINATE IN CF PATIENTS WITH PULMONARY PNEUMONIA AERUGINOSA

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。 这是一项III期研究，旨在评估在年龄≥ 6岁且FEV 1在25 - 75%预测值之间的囊性纤维化和Pa痰/喉培养阳性患者中，赖氨酸氨曲南吸入（AI）治疗28天的安全性和疗效。 这是一项双盲、随机、安慰剂对照、多国、多中心研究。 受试者将接受28天的75 mg AI或安慰剂治疗，每天使用eFlow雾化器给药3次。 本研究包括5次门诊访视-筛选、治疗第1、14、28天和2周随访访视。 只有少数抗生素被批准用于CF中Pa的吸入治疗。 氨曲南被批准用于IV给药，并对Pa有活性。 AI是与IV制剂不同的盐形式，以减轻肺刺激/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.