A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 28-DAY STUDY OF DENUFOSOL TETRAS

地纽福索 Tetras 的双盲、随机、安慰剂对照、为期 28 天的研究

• 批准号: 7606078
• 负责人: Carlos Milla
• 金额: $ 0.94万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606078
• 关键词: Age; Age-Years; Breathing; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Double-Blind Method; Funding; Grant; INS37217; Institution; Patients; Placebo Control; Pulmonary Cystic Fibrosis; Randomized; Research; Research Design; Research Personnel; Resources; Safety; Solutions; Source; Time; United States National Institutes of Health; age group; cystic fibrosis patients; day

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. The objectives of this study are to evaluate the safety and tolerability of two dose levels of Denufosol (INS37217) Inhalation Solution compared to palcebo administered three times daily over 28 days in patients with CF lung disease age 5 to 7 years of age. A second objective is to gain preliminary evidence of efficacy in this age group. In addition, the study will assess the feasibility of conducting this type of study is patients in this younger age group.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是评估 5 至 7 岁 CF 肺病患者在 28 天内每日 3 次给药的两种剂量水平的 Denufosol (INS37217) 吸入溶液的安全性和耐受性。第二个目标是获得该年龄组疗效的初步证据。此外，该研究还将评估针对这一较年轻年龄组的患者进行此类研究的可行性。