A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 33
- 主要终点
- Safety
研究概览
简要总结
The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease.
详细描述
While there are no FDA approved therapies for the treatment of IPF, there are therapies that have been shown to be effective in ameliorating the effects of pulmonary hypertension in patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However, these therapies have not been used extensively in patients with IPF who have pulmonary hypertension as a complication. The potential benefits of treatment of pulmonary hypertension complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary artery pressure and pulmonary vascular resistance, and increase in cardiac output.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria
- •Diagnosis of elevated pulmonary pressures
- •Six minute walk distance between 50-380
- •NYHA functional class II - IV
排除标准
- •Pulmonary fibrosis related to a systemic disorder
- •Significant chronic obstructive pulmonary disease
- •History of thromboembolic disease within the previous year
- •Awaiting lung transplantation within next 36 weeks
- •Active lung infection
- •Survival prognosis of less than 1 year
- •Significant left-sided heart failure, active coronary artery disease
- •Clinically relevant liver disease
- •Concurrent medications: epoprostenol, treprostinil, bosentan, PDE-5 inhibitor, investigational agents
结局指标
主要结局
Safety
次要结局
- 6 minute walk distance
- exercise associated oxygen desaturation