A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 6 Minute Walk Distance
研究概览
简要总结
The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
详细描述
Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath.
Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
- •FEV1/FVC ratio < 70%
- •FEV1 < 80%
- •Stable medication regimen
排除标准
- •COPD exacerbation or hospitalization in the past 3 months
- •Heart disease
- •Contraindication to sildenafil
- •Unrelated lung disease
- •Inability to walk or pedal on a stationary bike
- •Pregnancy or breast-feeding
- •Pulmonary hypertension at rest
研究组 & 干预措施
Sildenafil / Placebo
Sildenafil first, followed by washout, followed by placebo
干预措施: sildenafil citrate (Drug)
Sildenafil / Placebo
Sildenafil first, followed by washout, followed by placebo
干预措施: Placebo (Drug)
Placebo / Sildenafil
Placebo first, followed by washout, followed by Sildenafil
干预措施: sildenafil citrate (Drug)
Placebo / Sildenafil
Placebo first, followed by washout, followed by Sildenafil
干预措施: Placebo (Drug)
结局指标
主要结局
6 Minute Walk Distance
时间窗: Period 1 and Period 3 ( within 8 weeks)
The distance a subject walked within 6 minutes was measured and documented.
VO2 Peak (Oxygen Consumption at Peak Exercise)
时间窗: Period 1 and Period 3 ( within 8 weeks)
Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.
次要结局
- Pulmonary Function FVC (Forced Vital Capacity)(Period 1 (4 weeks))
- Forced Expiratory Volume in the First Second (FEV1 )(Period 1 ( 4 weeks))
- Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)(Period 1 and Period 3 ( within 8 weeks))
- Diffusing Capacity of Carbon Monoxide (DLCO)(Period 1 and Period 3 ( within 8 weeks))
- Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)(Period 1 and Period 3 ( within 8 weeks))
- Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)(Period 1 and Period 3 ( within 8 weeks))
- A-a Gradient (Alveolar-arterial Gradient)(Period 1 and Period 3 ( within 8 weeks))
- Oxygen Pulse(Period 1 and Period 3 ( within 8 weeks))
- O2 Saturation at Peak Exercise(Period 1 and Period 3 ( within 8 weeks))