Indoor Air and Children Health Study

Cardiopulmonary Disease Clinical Trial

Official title:

Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319056
• Other study ID #: FDeng17
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: May 2019
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in Beijing.

Description:

This randomized, double-blind crossover study was conducted to explore the cardiopulmonary effects of ionization air purification among 48 children in Beijing. Real or sham purification was performed in classrooms for 5 weekdays in a random order with a 2-month wash-out period. During the study periods, different indoor environmental factors were monitored including size-fractionated particulate matter (PM), black carbon (BC), ozone, carbon dioxide (CO2), negative air ions (NAI), noise, temperature and relative humidity, which were controlled as confounders in the analysis of the effects of indoor air purification. In addition, we analyzed the cardiopulmonary effects of those environmental factors on the children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• living in Beijing for more than two consecutive years;

• living in school dormitories from Monday to Friday.

Exclusion Criteria:

• suffering any health condition;

• having asthma or thoracic surgery history.

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Pulmonary Heart Disease

Intervention

Other:
• Air purifier
active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design

Locations

Country	Name	City	State
China	School of Pubic Health, Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of lung function indicators	Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).	10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary	Changes in autonomic cardiac function	Ambulatory electrocardiogram (ECG) was monitored including heart rate (HR) and heart rate variability (HRV).	10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary	Level of respiratory inflammation	Fractional exhaled nitric oxide (FeNO) test was conducted.	10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary	Changes in ST-segment elevation	Ambulatory electrocardiogram (ECG) was monitored.	10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary	Levels of oxidative stress in Exhaled Breath Condensate (EBC)	EBC was collected using a designated device for oxidative stress analysis.	10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary	Levels of urinary metabolomics	Urine samples were collected for metabolomics analysis.	10 weekdays for intervention (active or sham) and 2 wash-out months