Activated Macrophages and Ozone Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.
研究概览
简要总结
The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.
详细描述
Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood, urine, and exhaled breath samples will also be collected at each visit.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
排除标准
- •Cardiovascular disease
- •Respiratory disease
- •Pregnancy
- •HIV infection
- •History of smoking within the last 5 years
- •Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
- •Orthopedic or rheumatological conditions that would interfere with cycle use
结局指标
主要结局
Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.
时间窗: 72 hours after exposure.
Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.
时间窗: 24 hours after exposure.
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.
时间窗: 48 hours after exposure
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
次要结局
未报告次要终点
研究者
Howard M. Kipen, MD, MPH
Professor
Rutgers, The State University of New Jersey