Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Frequency of COPD Exacerbation
研究概览
简要总结
Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. But for some patients with severe COPD, current treatment only partially alleviates the symptoms and has little role in the lung function decline. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score and mMRC/CAT score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75
- •Gold Ⅲ or Ⅳ stable COPD
- •Pulmonary hypertension detected by echocardiography
排除标准
- •Acute exacerbation of chronic obstructive pulmonary disease
- •Untreated obstructive sleep apnea
- •Restrictive (total lung capacity<60% predicted) lung disease
- •Portal hypertension
- •Chronic liver disease
- •Transaminase increased to normal line more than 3 times; total bilirubin increased 2 times more than the upper limit of the normal value
- •Left-sided or unrepaired congenital heart disease
- •Patients with other serious heart diseases
- •Patients with 1, 2, 4 and 5 categories of pulmonary hypertension
- •Unable to complete the 6 minutes walk test
- •Patients receiving other endothelin receptor antagonists
- •No cooperation to complete
研究组 & 干预措施
Bosentan
Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.
干预措施: Bosentan (Drug)
Bosentan
Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.
干预措施: Symbicort turbuhaler (Drug)
Control
Inhaled Symbicort turbuhaler, 320/9μg, bid.
干预措施: Symbicort turbuhaler (Drug)
结局指标
主要结局
Frequency of COPD Exacerbation
时间窗: 12 months
次要结局
- 6-min-walk distance (6-MWD)(12 months)
- Lung Function(12 months)
- mMRC/CAT score(12 months)
- SGRQ score(12 months)
研究者
Shengqing Li
Associate Chief Physician, Associate Professor
Air Force Military Medical University, China