NCT03012646撤回2 期
A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Tolerability of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
United Therapeutics0 个研究点开始时间: 2017年4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
- 撤回
- 发起方
- 主要终点
- Incidence of Adverse Events Among Participants through 48 Weeks
研究概览
简要总结
This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of WHO Group 3 PH associated with COPD
- •Subjects are required to have a right heart catheterization (RHC) within one year prior to the first dose of study drug with the following parameters:
- •Pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) and
- •A left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) of ≤ 12 mmHg if PVR ≥ 4 WU to < 6.25 WU or ≤ 15 mmHg if PVR ≥ 6.25 WU and
- •A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg
- •Clinical Diagnosis of COPD will be made using accepted Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria, including Baseline spirometry with the following documented parameters:
- •FEV1 < 65% predicted, and
- •FEV1/ FVC < 70
- •Baseline 6MWD ≥ 100 meters
- •Exclusion criteria:
- •The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than COPD as outlined in inclusion criterion
- •This would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma, or systemic lupus erythematosus), sarcoidosis, interstitial lung disease,human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
- •The subject has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (ie, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist [ERA], phosphodiesterase type 5 inhibitor [PDE5-I],or soluble guanylate cyclase [sGC] stimulator) within 60 days of the first dose of study drug, except for acute vasoreactivity testing.
- •The subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment:
- •Left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) >15 mmHg (or >12 mmHg if pulmonary vascular resistance [PVR] ≥4 to <6.25 WU)
- •Left ventricular ejection fraction <40% as assessed by either angiography or echocardiography.
排除标准
- 未提供
研究组 & 干预措施
Active Inhaled Treprostinil
Experimental
Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
干预措施: Inhaled Treprostinil (Drug)
结局指标
主要结局
Incidence of Adverse Events Among Participants through 48 Weeks
时间窗: 48 weeks
The incidence of adverse events among participants throughout the 48-week study will be measured by the number of participants analyzed and the percentage of those participants who experienced an adverse event.
次要结局
- Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48(Baseline and Week 48)
- Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48(Baseline and Week 48)
- Change in Forced Vital Capacity (FVC) from Baseline to Week 48(Baseline and Week 48)
- Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48(Baseline and Week 48)
- Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48(Baseline and Week 48)
- Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48(Baseline and Week 48)
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