A PHASE 3, DOUBLE-BLIND, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL WITH

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。 本研究旨在评估吸入用赖氨酸氨曲南（AI，Cayston）治疗28天的安全性和疗效，以及吸入用妥布霉素溶液（TSI，TOBI）治疗28天后，AI维持或改善肺铜绿假单胞菌（PA）囊性纤维化（CF）患者临床状态的能力。本研究的主要终点是评价至需要吸入或IV抗生素的时间。

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 study is designed to assess the safety and efficacy of a 28-day treatment with Aztreonam Lysinate for Inhalation (AI, Cayston) and the ability of AI to maintain or improve clinical status following a 28-day course of Tobramycin Solution for Inhalation (TSI, TOBI) therapy in cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA). The primary endpoint of this study is to evaluate the time to need for inhaled or IV antibotics.