NCT01266434已完成3 期
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Sputum eosinophils
研究概览
简要总结
To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild-to-moderate persistent asthmatics
- •FEV1 = OR > 50% of predicted
排除标准
- •Previous history of renal disease or serum creatinine is more than 2 mg/dl.
- •Previous history of liver disease.
- •Pregnancy or lactation.
- •Are already receiving or are known to be allergic to statins or to have developed myositis.
- •Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
- •Being treated with immunosuppressive agents.
- •Unwilling to cooperate the study.
研究组 & 干预措施
simvastatin
Experimental
干预措施: Simvastatin (Drug)
B1-6-12
Placebo Comparator
干预措施: Simvastatin (Drug)
B1-6-12
Placebo Comparator
干预措施: B1-6-12 (Drug)
结局指标
主要结局
Sputum eosinophils
时间窗: 8 weeks
To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum and on lung function (FEV1)
次要结局
- Phosphorylated p38 MAPK in sputum cells(8 weeks)
研究者
Kittipong Maneechotesuwan
Professor
Mahidol University
研究点 (1)
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