Acute Health Effects of Ozone Exposure

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Haidong Kan，Fudan University

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

December 3, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes of FEV1[ Time Frame: 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[ Time Frame: 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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Acute Health Effects of Ozone Exposure

Official Title ^ICMJE

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

Brief Summary

This is a randomized controlled human exposure crossover study. We 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 15 minutes of rest and 15 minutes of exercise on a treadmill. The exercise workload will be adjusted to achieve the targeted ventilation of 20±1 L/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 50%±5%, respectively. Health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Basic Science

Condition ^ICMJE

Intervention ^ICMJE

Other: 200 ppb ozone group
The exposure group will be exposed to 200 ppb ozone in a chamber for 2 hours while alternating 15-min rest and 15-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 20±1 L/min/m2 body surface area. The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 50%±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 15-min rest and 15-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 20±1 L/min/m2 body surface area. The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 50%±5%, respectively.

Study Arms

Experimental: Exposure group
Subjects in exposure group will be exposed to 200 ppb ozone for 2 hours in a chamber.
Sham Comparator: Control group
Subjects in control group will be exposed to 0 ppb ozone (clean air) for 2 hours in a chamber.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

December 3, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Living in Shanghai during study period; - Ability to complete the exercise to achieve the ventilation of 20±1 L/min/m2 body surface area; - Body mass index >18.5 and ≤30 (30 is the lower limit for class 2 obesity for Chinese). Exclusion Criteria: - 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).

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Haidong Kan，Fudan University

Study Sponsor ^ICMJE

Fudan University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Haidong Kan, Ph.D Department of Environmental Health, School of Public Health, Fudan University

PRS Account

Fudan University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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