Effect of Statin Therapy on C-reactive Protein Levels in Patients With COPD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- serum CRP levels
研究概览
简要总结
Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.
详细描述
Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation, which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that activates the acute phase CRP response.
Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.
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
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically optimized COPD patients
- •Age 40-79 years.
- •serum CRP levels >3mg/l
排除标准
- •Current smoker
- •COPD exacerbation in the last 2 months.
- •Active hepatic or severe renal dysfunction.
- •connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (>10,000 white blood cells) or thrombocytosis (>450,000 platelets).
- •Recent h/o myocardial infarction, angina in the last 6 months.
- •Pregnancy.
研究组 & 干预措施
1
placebo drug
干预措施: simvastatin (Drug)
2
simvastatin
干预措施: simvastatin (Drug)
结局指标
主要结局
serum CRP levels
时间窗: 9 weeks
次要结局
未报告次要终点
研究者
James D. Anholm, M.D.
Principal Investigator
VA Loma Linda Health Care System