NCT00792337已完成3 期
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids 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
- 53
- 试验地点
- 1
- 主要终点
- Sputum eosinophil
研究概览
简要总结
We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients
详细描述
To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum
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
- •He or she has FEV1 > 60% of predicted
- •He or she requires less than 1000 mcg daily of beclomethasone or equivalent
排除标准
- •He or she had previous history of renal disease or serum creatinine more than 2 mg/dL
- •He or she had previous history of liver disease
- •She is pregnant or during lactation
- •He or she has already received statins or is allergic to statins or has developed myositis.
- •He or she has an asthma exacerbation and requires treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
研究组 & 干预措施
simvastatin
Active Comparator
simvastatin in combination with budesonide
干预措施: simvastatin (Drug)
B1-6-12
Placebo Comparator
Budesonide in combination with B1-6-12
干预措施: B1-6-12 (Drug)
结局指标
主要结局
Sputum eosinophil
时间窗: 8 WEEKS
次要结局
- FEV1(8 WEEKS)
- PC20(8 weeks)
研究者
Kittipong Maneechotesuwan
Professor
Mahidol University
研究点 (1)
Loading locations...
相似试验
尚未招募
4 期
A clinical trial to study the effects of Simvastatin on reduction in inflammation and improvement in functional status of patients with knee joint pains.CTRI/2014/03/004469Indian Council of Medical Research New Delhi180
已完成
3 期
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in AsthmaAsthmaNCT01266434Mahidol University44
已完成
不适用
Effect of Simvastatin on inflammatory marker and improvement of GFR in CRF patientChronic Renal Failure.Diseases of the genitourinary systemIRCT138712071698N3Shiraz University of Medical Sciences40
已完成
3 期
Simvastatin Addition for Patients With Recent-onset SchizophreniaSchizophreniform DisorderPsychosis NOSSchizoaffective DisorderSchizophreniaNCT01999309Iris Sommer121
终止
不适用
Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary InterventionCoronary Artery DiseaseNCT00588471Mayo Clinic57