NCT01580748Unknown2 期
Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- change of CASA-Q score
研究概览
简要总结
There is currently no effective treatment of bronchiectasis other than treating its complications such as infection, bleeding, etc. Roflumilast is a newly developed anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that Roflumilast might be effective in symptomatic bronchiectasis patients
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bronchiectasis on CT
- •chronic (>3 months) cough or sputum
排除标准
- •needs hospitalization
- •life expectancy of less than six months
- •pregnancy or breast feeding
- •history of acute respiratory infection within 4 weeks
- •history of taking antibiotics within 4 weeks
- •active hemoptysis
- •%predicted FEV < 30%
- •severe liver disease (Child Pugh Class B or C)
研究组 & 干预措施
Treatment arm
Experimental
single arm study
干预措施: Roflumilast (Drug)
结局指标
主要结局
change of CASA-Q score
时间窗: 16 weeks
次要结局
- alanine transaminase(4 weeks)
- change of FEV1(16 weeks)
- change of FVC(16 weeks)
研究者
Hoil Yoon
Professor
Seoul National University Bundang Hospital
研究点 (1)
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