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

一项 3 期、双盲、多中心、随机、安慰剂对照试验

• 批准号: 7375983
• 负责人: Carlos Milla
• 金额: $ 2.47万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375983
• 关键词: PHASE; DOUBLE; BLIND; MULTICENTER; RANDOMIZED

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究旨在评估氨曲南赖氨酸盐雾化吸入(AI，Cayston)28天的安全性和有效性，以及在28天的妥布霉素雾化溶液(TSI，TOBI)治疗后，AI维持或改善临床状况的能力。这项研究的主要目的是评估吸入性或静脉注射抗菌素所需的时间。