Back to resultsIndoor Air and Children Health Study
Primary Purpose
Cardiopulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Air purifier
Sponsored by
About this trial
This is an interventional prevention trial for Cardiopulmonary Disease
Eligibility Criteria
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.
Sites / Locations
- School of Pubic Health, Peking University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Real purification
Sham purification
Arm Description
Air purifier turned on
Air purifier turned off
Outcomes
Primary Outcome Measures
Levels of lung function indicators
Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).
Secondary Outcome Measures
Changes in autonomic cardiac function
Ambulatory electrocardiogram (ECG) was monitored including heart rate (HR) and heart rate variability (HRV).
Level of respiratory inflammation
Fractional exhaled nitric oxide (FeNO) test was conducted.
Changes in ST-segment elevation
Ambulatory electrocardiogram (ECG) was monitored.
Levels of oxidative stress in Exhaled Breath Condensate (EBC)
EBC was collected using a designated device for oxidative stress analysis.
Levels of urinary metabolomics
Urine samples were collected for metabolomics analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03319056
Brief Title
Indoor Air and Children Health Study
Official Title
Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real purification
Arm Type
Active Comparator
Arm Description
Air purifier turned on
Arm Title
Sham purification
Arm Type
Sham Comparator
Arm Description
Air purifier turned off
Intervention Type
Other
Intervention Name(s)
Air purifier
Intervention Description
active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design
Primary Outcome Measure Information:
Title
Levels of lung function indicators
Description
Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).
Time Frame
10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary Outcome Measure Information:
Title
Changes in autonomic cardiac function
Description
Ambulatory electrocardiogram (ECG) was monitored including heart rate (HR) and heart rate variability (HRV).
Time Frame
10 weekdays for intervention (active or sham) and 2 wash-out months
Title
Level of respiratory inflammation
Description
Fractional exhaled nitric oxide (FeNO) test was conducted.
Time Frame
10 weekdays for intervention (active or sham) and 2 wash-out months
Title
Changes in ST-segment elevation
Description
Ambulatory electrocardiogram (ECG) was monitored.
Time Frame
10 weekdays for intervention (active or sham) and 2 wash-out months
Title
Levels of oxidative stress in Exhaled Breath Condensate (EBC)
Description
EBC was collected using a designated device for oxidative stress analysis.
Time Frame
10 weekdays for intervention (active or sham) and 2 wash-out months
Title
Levels of urinary metabolomics
Description
Urine samples were collected for metabolomics analysis.
Time Frame
10 weekdays for intervention (active or sham) and 2 wash-out months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Furong Deng, PhD&MD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Pubic Health, Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
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Indoor Air and Children Health Study
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