TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).
研究概览
简要总结
An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)
详细描述
This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between the ages of 30 and 80
- •have a clinical diagnosis of Gold stage 2 to 4 COPD
- •have a diagnosis of pulmonary hypertension established by a historic right heart catheterization
- •a minimum weight of 45 Kg
- •minimum systolic blood pressure of >90 mmHg
- •be able to perform a six minute walk test
- •be able to maintain a oxygen saturation >88% at rest (with or without oxygen)
- •be treated with background therapy for COPD for a minimum of 1 month prior to consideration of enrollment.
- •be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedure.
- •Exclusion Criteria. Cannot have or be:
- •The presence of pulmonary venous hypertension defined by a historical right heart catheterization
- •Gold Stage I COPD
- •documented left ventricular dysfunction as measured by echocardiography
- •pregnant or breastfeeding
- •Recipient of a lung transplant
- •received chronic prostanoid therapy for pulmonary hypertension within 4 weeks prior to the screening appointment
- •A requirement of greater than 9 l/min of O2 to maintain oxygen saturations greater than 88% at rest
- •No other serious medical conditions
排除标准
- 未提供
研究组 & 干预措施
Treprostinil
Inhaled prostanoid therapy with Treprostinil
干预措施: Inhaled Treprostinil Therapy (Drug)
结局指标
主要结局
To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).
时间窗: This is a 4 week trial
A 4-Week, Open Label Study Testing the Safety of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Lung Disease (COPD) (PH-COPD)
次要结局
- New York Heart Association (NYHA) functional class(Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.)
- Six minute walk distance(Change from baseline in 6 minute walk distance at 4 weeks)
- Clinical Worsening(From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks)
- Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression(Change from baseline in PBMC PI and PBMC gene expression at 4 weeks)
- St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire(change from baseline in the St. George's respiratory questionnaire at 4 weeks)