Acute Health Effects of Ozone Exposure

NCT ID: NCT03697174

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-07
• Study Completion Date: 2019-10-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Exposure group

Subjects in exposure group will be exposed to 200 ppb ozone for 2 hours in a chamber.

Group Type: EXPERIMENTAL

200 ppb ozone group

Intervention Type: OTHER

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.

Control group

Subjects in control group will be exposed to 0 ppb ozone (clean air) for 2 hours in a chamber.

Group Type: SHAM_COMPARATOR

0 ppb ozone group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haidong Kan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haidong Kan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Environmental Health, School of Public Health, Fudan University

Locations

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, , China

Countries

China

References

Niu Y, Chen R, Wang C, Wang W, Jiang J, Wu W, Cai J, Zhao Z, Xu X, Kan H. Ozone exposure leads to changes in airway permeability, microbiota and metabolome: a randomised, double-blind, crossover trial. Eur Respir J. 2020 Sep 3;56(3):2000165. doi: 10.1183/13993003.00165-2020. Print 2020 Sep. No abstract available.

Reference Type: DERIVED

PMID: 32299865 (View on PubMed)

Other Identifiers

FDUEH-5

Identifier Type: -

Identifier Source: org_study_id