Phase IV Study on the Effects of Sildenafil in Combination With Pulmonary Rehabilitation Program on Exercise Tolerance in Patients With COPD and Pulmonary Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Endurance time
研究概览
简要总结
Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.
详细描述
It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD, FEV1 < 80% ref. and FEV1/FVC < 0.7 post bronchodilator
- •Age 40-80 years
- •Pulmonary hypertension
- •Consent to participate in the study
排除标准
- •Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics
- •Recent exacerbation (<4 weeks) (temporally)
- •Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir)
- •Ischemic optic neuropathy
- •Patients treated with phosphodiesterase-5 inhibitors
- •Patients with ischemic cardiopathy
- •Systemic disease that could modified the results
- •Patients unable to practise exercise
研究组 & 干预措施
Sildenafil plus pulmonary rehabilitation
干预措施: Sildenafil (Drug)
Placebo plus pulmonary rehabilitation
干预措施: Placebo (Other)
结局指标
主要结局
Endurance time
时间窗: 3 months
次要结局
- 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life(3 months)
研究者
Joan Albert Barbera Mir
MD
Hospital Clinic of Barcelona