跳至主要内容
临床试验/NCT00205634
NCT00205634已完成2 期

Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Wake Forest University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2000年12月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Pulmonary Function Testing - FEV1

研究概览

简要总结

The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
6 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of CF
  • ability to reliably perform spirometry
  • FEV1 of 30% predicted at the time of screening

排除标准

  • Mycobacterium in a sputum culture ever recorded
  • a respiratory exacerbation requiring IV antibiotics in the 60 days prior
  • used a investigational drug or device in the 60 days prior
  • significant (>30ml) of hemoptysis in the past year
  • require oxygen or have significant liver or renal disease

结局指标

主要结局

Pulmonary Function Testing - FEV1

Quality of Life

次要结局

  • decrease in neutrophil-dominated airway inflammation
  • decrease in Pseudomonas alginate production in vitro and in the airway

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验