Acute Health Effects of Ozone Exposure

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Fudan University

Status

Completed

Conditions

Pulmonary Function

Treatments

Other: 200 ppb ozone group
Other: 0 ppb ozone group

Study type

Interventional

Funder types

Other

Identifiers

NCT03697174
FDUEH-5

Details and patient eligibility

About

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

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

32 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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