Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Endothelial Dysfunction (Arterial Stiffness)
研究概览
简要总结
To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind, placebo control study. Population: 18 males with stable COPD between 40-80 years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted post-bronchodilation.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Stable COPD between 40-80 years of age, exsmokers, with FEV1 lower that 80% predicted post-bronchodilation.
排除标准
- •Severe co-morbidity (advanced-stage cancer, tuberculosis affecting more than a third of the total lung parenchyma, pneumonectomy, pneumoconiosis, left cardiac failure previously reported, known cardiopathy with ventricular dysfunction (ejection fraction < 45%) or any cardiovascular disease, Diabetes Mellitus treated with insulin, Hypercholesterolemia, Chronic inflammatory diseases (asthma, rheumatoid arthritis, lung fibrosis, autoimmune diseases), Treatment with systemic steroid, non steroidal anti-inflammatory drugs or stains within 3 months prior to inclusion.
研究组 & 干预措施
Simvastatin
Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks
干预措施: Simvastatin (Drug)
Placebo
Patients with COPD will receive placebo once a day during 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Endothelial Dysfunction (Arterial Stiffness)
时间窗: Day 1 and day 84 (end of of week 12)
次要结局
- Systemic inflammation(Day 1 and day 84 (end of of week 12))
- BODE index(Day 1 and day 84 (end of of week 12))
- Uric acid(Day 1 and day 84 (end of of week 12))
- Vascular growth factors(Day 1 and day 84 (end of of week 12))
研究者
Ernest Sala
Medical Doctor
Hospital Son Espases