NCT01437878终止2 期
A Phase 2, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Inhaled Iloprost on Endurance Time During Cardiopulmonary Exercise Testing in Patients With Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease
Actelion11 个研究点 分布在 3 个国家目标入组 2 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 11
- 主要终点
- Change in Endurance Time
研究概览
简要总结
This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study mandated procedure
- •Male or female ≥ 40 and ≤ 75 years of age
- •Women of childbearing potential1 must use a reliable method of contraception
- •Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
- •Current or past smokers of ≥ 10 pack years
- •Ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator)
- •Confirmed pulmonary hypertension by right heart catheterization (RHC)
排除标准
- •Other causes of pulmonary hypertension than COPD
- •BMI > 35 kg/m2
- •Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
- •Pregnant or nursing
- •Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
- •Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to RHC visit
- •Known concomitant life-threatening disease with a life expectancy < 12 months
- •Known hypersensitivity to iloprost or any of the excipients of the drug formulations
研究组 & 干预措施
placebo
Placebo Comparator
matching placebo using the power disc-6 with I-neb AAD system
干预措施: Placebo (Drug)
iloprost
Experimental
single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system
干预措施: Iloprost (Drug)
结局指标
主要结局
Change in Endurance Time
时间窗: Baseline to week 4
Change from baseline to week 4 in endurance time during constant work rate exercise testing
次要结局
- Change in Cardiac Output(15 minutes)
- Change in End Tidal Partial Pressure of Oxygen(Baseline to week 4)
- Change in Systolic Pulmonary Arterial Pressure(15 minutes)
- Change in Mean Right Atrial Pressure(15 minutes)
- Change in Right Ventricular Pressure(15 minutes)
- Change in Pulmonary Vascular Resistance(15 minutes)
- Change in Diastolic Pulmonary Arterial Pressure(15 minutes)
- Change in End Tidal Partial Pressure of Carbon Dioxide(Baseline to week 4)
- Change in Oxygen Uptake(Baseline to week 4)
- Change in Carbon Dioxide Output(Baseline to week 4)
- Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry(Baseline to week 4)
- Change in Tidal Volume(Baseline to week 4)
- Participants With Treatment-emergent Adverse Events(Baseline up to 24 hours post-EOT, approximately 4 weeks)
- Change in Mean Pulmonary Arterial Pressure(15 minutes)
- Change in Heart Rate(Baseline to week 4)
- Change in Oxygen Uptake Per Heartbeat(Baseline to week 4)
- Change in Minute Ventilation(Baseline to week 4)
研究者
研究点 (11)
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