Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes of FEV1
研究概览
简要总结
This is a randomized controlled human exposure crossover study. Investigators aim to investigate the acute health effects of ozone exposure in healthy young adults.
详细描述
The investigators will conduct a randomized controlled human exposure crossover study among 32 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to clean air and once to 200 ppb ozone in a chamber for 2 hours. During the 2-hour exposure, each subject will be requested to alternate 20 minutes of rest and 10 minutes of exercise on a treadmill. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). Ozone will be generated by a silent electric discharge method (HTU-500, AZCO Industries Ltd., Canada) and introduced into the chamber. The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively. Health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning. Health examinations include symptom questionnaire, skin tests, spirometry, and Holter monitoring. We plan to collect blood, buccal, urine, nasal secretion, saliva, exhaled breath condensate, sebum, and D-squame samples.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in Shanghai during study period;
- •Ability to complete the exercise to achieve the ventilation of 15 to 18 L/min/m2 body surface area;
- •Body mass index >18.5 and ≤30.0 (30 is the lower limit for class 2 obesity for Chinese).
排除标准
- •Smoking and alcohol abuse;
- •Current drug and dietary supplements intake;
- •Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
- •Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
- •Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
- •Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
- •Subjects who have a history of major surgery;
- •Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
- •Abnormal baseline 12-lead resting electrocardiogram;
- •Abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (GPT).
结局指标
主要结局
Changes of FEV1
时间窗: FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Changes of forced expiratory volume in 1 second
Changes of FVC
时间窗: FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Changes of forced vital capacity
次要结局
- HRV(Holter monitoring will be performed continuously for 24 hours.)