NCT01944176已完成3 期
The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokines in COPD Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sputum cytokines
研究概览
简要总结
Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines 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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable COPD without an exacerbation within 3 months prior to study entry
- •mild, moderate and severe COPD with or without treatments, regardless of COPD medications
排除标准
- •Concomitant other chronic lung diseases including with TB and malignancy
- •Being on immunosuppressive drugs and systemic corticosteroids
- •Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
- •Cognitive impairment
- •Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine
研究组 & 干预措施
Simvastatin
Experimental
simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks
干预措施: simvastatin, placebo (Drug)
B1-6-12
Placebo Comparator
B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks
干预措施: simvastatin, placebo (Drug)
结局指标
主要结局
Sputum cytokines
时间窗: Up to 4 weeks
次要结局
- FEV1(Up to 4 weeks)
- Sputum neutrophils(Up to 4 weeks)
研究者
Kittipong Maneechotesuwan
Professor
Mahidol University
研究点 (1)
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