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临床试验/NCT00547053
NCT00547053已完成1 期

A Six Month Open Label Study of Amiloride Solution for Inhalation and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年12月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
25
试验地点
2
主要终点
Eradication of Burkholderia dolosa.

研究概览

简要总结

The purpose of this research study is to determine if multiple doses of two inhaled drugs will help Cystic Fibrosis patients whose lungs are infected with a bacteria called Burkholderia dolosa. The names of these drugs are tobramycin solution for inhalation and amiloride solution for inhalation. Currently, treating patients with Burkholderia dolosa infections is challenging because the bacteria is resistant to antibiotics. Therefore, researchers are looking for drugs which, when taken with an antibiotic, will help the antibiotic to work more effectively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Cystic Fibrosis
  • Two positive cultures for Burkholderia dolosa lung infection

排除标准

  • Positive pregnancy test or currently breast feeding (if applicable)
  • Known sensitivity to Amiloride

结局指标

主要结局

Eradication of Burkholderia dolosa.

时间窗: 1 month, 3 months, and 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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