A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- 6-minute-walk Distance (6MWD)
研究概览
简要总结
Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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,
- •Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV.
- •Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.
排除标准
- •Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
- •Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg),
- •Known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
- •Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
- •Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
- •Pregnant or breast-feeding women,
- •Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
- •Systolic blood pressure < 95 mmHg,
- •Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
- •Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
- •Clinically relevant bleeding disorder or active bleeding,
- •For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
- •Known hypersensitivity to iloprost or any of its excipients.
研究组 & 干预措施
Active / placebo
Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3
干预措施: iloprost (5 µg) (Drug)
Active / placebo
Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3
干预措施: placebo (Drug)
Placebo / active
Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3
干预措施: iloprost (5 µg) (Drug)
Placebo / active
Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3
干预措施: placebo (Drug)
结局指标
主要结局
6-minute-walk Distance (6MWD)
时间窗: Study day 2 or study day 3
The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk. It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization.
次要结局
- Borg Dyspnea Score(Study day 2 or study day 3)