A Study of the Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Center Reference Endotoxin in Normal Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE
研究概览
简要总结
The investigators want to see if healthy people who are given 2 doses of a medication called anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then exposed to a form of air pollution, called Endotoxin, have less inflammation with the medication. Endotoxin is believed to be one of the causes of asthma attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
- •age 18-50 years
排除标准
- •pregnant women
研究组 & 干预措施
Anakinra
All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
干预措施: Anakinra (Drug)
Placebo
Normal saline injection
干预措施: Placebo (Drug)
结局指标
主要结局
blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE
时间窗: 6 hours after inhalation of CCRE
The primary endpoints for this study will be a) safety assessments of anakinra with CCRE inhalation and b) the post CCRE challenge percentage of neutrophils (%PMN) in airway sputum during the anakinra treatment period compared to the placebo treatment period.
次要结局
未报告次要终点
研究者
Michelle Hernandez, MD
Assistant Professor
University of North Carolina, Chapel Hill