Acute Health Effects of Ozone Exposure

NCT03697174 | Completed

• 1 other identifier: FDUEH-5
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Function

Outcome Measures

Primary Outcomes (2)

• Changes of FEV1

  Changes of forced expiratory volume in 1 second

  FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning

• Changes of FVC

  Changes of forced vital capacity

  FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning

Secondary Outcomes (1)

• HRV

  Holter monitoring will be performed continuously for 24 hours.

Other Outcomes (16)

• Difference in CRF concentrations between the two exposures

  2 hours after the completion of exposure.

• Difference in ACTH concentrations between the two exposures

  2 hours after the completion of exposure.

• Difference in cortisol concentrations between the two exposures

  2 hours after the completion of exposure

Study Arms (2)

Exposure group

EXPERIMENTAL

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

Other: 200 ppb ozone group

Control group

SHAM COMPARATOR

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

Other: 0 ppb ozone group

Interventions

200 ppb ozone group 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.

Exposure group

0 ppb ozone group 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.

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 32299865 DERIVED

Study Officials

• Haidong Kan, Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 5, 2018
• Study Start: October 7, 2018
• Primary Completion: December 9, 2018
• Study Completion: October 12, 2019
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)