NCT01659307已完成2 期
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Bronchoalveolar lavage IL-8 concentration
研究概览
简要总结
This is a double-blind, placebo-controled, randomized trial to investigate if aspirin pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
排除标准
- •Age < 18 years
- •Pregnancy or breast feeding or woman of childbearing potential not using
- •adequate contraception.
- •Participation in a clinical trial of an investigational medicinal product within 30 days
- •Consent declined Aspirin or non steroidal anti-inflammatory (NSAID) use in the past 4 weeks
- •History of asthma
- •Known aspirin or NSAID hypersensitivity
- •History of peptic ulcer disease
- •Platelet count < 150 x 106/ml
- •Aspirin resistance
研究组 & 干预措施
Aspirin 75mg
Active Comparator
Aspirin 75mg once daily for 7 days. Administered by mouth.
干预措施: Aspirin 75mg (Drug)
Aspirin 1200mg
Active Comparator
Asprin 600mg twice daily for 7 days. Administered by mouth.
干预措施: Aspirin 1200mg (Drug)
Lactose powder
Placebo Comparator
Placebo for 7 days. Administered by mouth.
干预措施: Lactose powder (Drug)
结局指标
主要结局
Bronchoalveolar lavage IL-8 concentration
时间窗: 6 hrs after LPS inhalation
次要结局
- Plasma inflammatory response biomarkers(6 and 24 hrs after LPS inhalation)
- Alveolar inflammatory response biomarkers(6 hrs after LPS inhalation)
- Alveolar epithelial and endothelial function and injury biomarkers(6 hrs after LPS inhalation)
- Lipid inflammatory mediators(6 and 24 hrs after LPS inhalation)
研究者
Professor Danny McAuley
Professor of Intensive care Medicine
Belfast Health and Social Care Trust
研究点 (1)
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