Clinical trial NCT03697174: Acute Health Effects of Ozone Exposure
Official title: Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Function
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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).

Primary outcomes:
measure: Changes of FEV1
timeFrame: FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
measure: Changes of FVC
timeFrame: FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Secondary outcomes:
measure: HRV
timeFrame: Holter monitoring will be performed continuously for 24 hours.
Other outcomes:
measure: Difference in CRF concentrations between the two exposures
timeFrame: 2 hours after the completion of exposure.
measure: Difference in ACTH concentrations between the two exposures
timeFrame: 2 hours after the completion of exposure.
measure: Difference in cortisol concentrations between the two exposures
timeFrame: 2 hours after the completion of exposure
measure: Difference in adrenaline concentrations between the two exposures
timeFrame: 2 hours after the completion of exposure.
measure: Difference in noradrenaline concentrations between the two exposures
timeFrame: 2 hours after the completion of exposure.
measure: Change in the amount of skin moisture
timeFrame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.
measure: Change in L-values
timeFrame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.
measure: Change in a-values
timeFrame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.
measure: Change in b-values
timeFrame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.
measure: Difference in alpha diversity of microbiota between the two exposures
timeFrame: Immediately after the completion of exposure
measure: Change in CC16 concentrations
timeFrame: Immediately before exposure, 2 hours after the completion of exposure, and next morning
measure: Differences in metabolite levels detected in serum metabolomics between the two exposures
timeFrame: 2 hours after the completion of exposure
measure: Differences in metabolite levels detected in airway metabolomics between the two exposures
timeFrame: 2 hours after the completion of exposure
measure: Differences in metabolite levels detected in urine metabolomics between the two exposures
timeFrame: Immediately after the completion of exposure
measure: Differences in RNA expression levels detected in transcriptomics between the two exposures
timeFrame: 2 hours after the completion of exposure
measure: Differences in protein levels detected in serum proteomics between the two exposures
timeFrame: 2 hours after the completion of exposure
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
Study officials:
affiliation: Department of Environmental Health, School of Public Health, Fudan University
name: Haidong Kan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.