NCT03697174

Acute Health Effects of Ozone Exposure

Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This is a randomized controlled human exposure crossover study. Investigators aim to investigate the acute health effects of ozone exposure in healthy young adults.

Detailed description

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.

Conditions

• Pulmonary Function

Interventions

Type	Name	Description
OTHER	200 ppb ozone group	The exposure group will be exposed to 200 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. 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). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.
OTHER	0 ppb ozone group	The control group will be exposed to 0 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. 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). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.

Timeline

• Start date: 2018-10-07
• Primary completion: 2018-12-09
• Completion: 2019-10-12
• First posted: 2018-10-05
• Last updated: 2021-07-22

Locations

1 site across 1 country: China