Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- change from baseline in 6-min-walk distance (6-MWD)
研究概览
简要总结
Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.
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
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 10 to 80
- •treatment naive symptomatic PAH
- •6-MWD of 100-425 m
- •resting mean pulmonary artery pressure greater than 25 mm Hg, pulmonary capillary wedge pressure less than 15 mm Hg, and pulmonary vascular resistance of 240 dyn.s.cm-5 or greater.
排除标准
- •Patients with thromboembolic disease,
- •untreated obstructive sleep apnea,
- •portal hypertension,
- •chronic liver disease or renal insufficiency,
- •left-sided or unrepaired congenital heart disease,
- •substantial obstructive (FEV1/FVC<50% predicted) or restrictive (total lung capacity<60% predicted) lung disease
- •Patients receiving phosphodiesterase inhibitors or other prostanoids and endothelin receptor antagonists
研究组 & 干预措施
Combination therapy
combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
干预措施: Iloprost (Drug)
Combination therapy
combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
干预措施: Bosentan (Drug)
monotherapy
Bosentan,125mg,po,bid.
干预措施: Bosentan (Drug)
结局指标
主要结局
change from baseline in 6-min-walk distance (6-MWD)
时间窗: 12 weeks
次要结局
- modified (NYHA) functional class(12 weeks)
研究者
Shengqing Li
Associate Chief Physician, Associate Professor
Air Force Military Medical University, China