NCT00205634已完成2 期
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
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
- 否
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
研究点 (2)
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