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CompletedNCT03319056Updated May 23, 2019

Indoor Air and Children Health Study

An interventional study of Air purifier in Cardiopulmonary Disease, sponsored by Peking University. Completed at 1 site in China. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-23.

Sponsored by Peking University · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
10 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiopulmonary Disease
03

In context

Pulmonary Heart Disease

42 studies on the registry are indexed under Pulmonary Heart Disease; 6 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 23 interventional studies indexed under Pulmonary Heart Disease.

Browse Pulmonary Heart Disease studies →

Lead sponsor

Peking University is the lead sponsor of 419 studies on the registry; 123 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • living in Beijing for more than two consecutive years;
  • living in school dormitories from Monday to Friday.

Exclusion criteria

Exclusion Criteria:

  • suffering any health condition;
  • having asthma or thoracic surgery history.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Real purification

    Air purifier turned on

    Other: Air purifier

  • Sham comparator
    Sham purification

    Air purifier turned off

    Other: Air purifier

Interventions

  • OtherAir purifier

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

06

What researchers measure

Primary outcomes

  1. Levels of lung function indicators

    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 outcomes

  1. Changes in autonomic cardiac function

    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

  2. Level of respiratory inflammation

    Fractional exhaled nitric oxide (FeNO) test was conducted.

    Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months

  3. Changes in ST-segment elevation

    Ambulatory electrocardiogram (ECG) was monitored.

    Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months

  4. Levels of oxidative stress in Exhaled Breath Condensate (EBC)

    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

  5. Levels of urinary metabolomics

    Urine samples were collected for metabolomics analysis.

    Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months

07

Study locations

1 site
  • School of Pubic Health, Peking University
    Beijing, Beijing 100191, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Apr 2018, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Oct 24, 2017
StartActual
Dec 11, 2017
Primary completionActual
Apr 1, 2018
CompletionActual
Apr 1, 2018
Last update
May 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03319056
Lead sponsor
Peking University
Responsible party
Furong Deng (MD & PhD, Professor, Deputy Director of Department of Occupational & Environmental Health Sciences, Peking University) — Principal investigator
First posted
Oct 24, 2017
Start date
Dec 11, 2017
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
May 23, 2019

Study contacts

Furong Deng, PhD&MD
principal investigator · Peking University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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