Cardiopulmonary DiseaseNCT03319056
Indoor Air and Children Health Study
A study testing Air purifier in people with Cardiopulmonary Disease, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Disease
- What is being tested?
- Air purifier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- living in Beijing for more than two consecutive years;
- living in school dormitories from Monday to Friday.
Who cannot join
- suffering any health condition;
- having asthma or thoracic surgery history.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Pubic Health, Peking University
Beijing, Beijing Municipality, 100191
About this study
Official title: Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing
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.
- Conditions
- Cardiopulmonary Disease
- Being tested
- Air purifier
- Medical subject headings
- Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifierOther
active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design
| Study group | Role | What they receive |
|---|---|---|
| Real purification | Active comparator | Air purifier turned on Receives: Other: Air purifier |
| Sham purification | Sham comparator | Air purifier turned off Receives: Other: Air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of lung function indicators
Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).
Measured: 10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary outcomes (5)
Changes in autonomic cardiac function
Ambulatory electrocardiogram (ECG) was monitored including heart rate (HR) and heart rate variability (HRV).
Measured: 10 weekdays for intervention (active or sham) and 2 wash-out months
Level of respiratory inflammation
Fractional exhaled nitric oxide (FeNO) test was conducted.
Measured: 10 weekdays for intervention (active or sham) and 2 wash-out months
Changes in ST-segment elevation
Ambulatory electrocardiogram (ECG) was monitored.
Measured: 10 weekdays for intervention (active or sham) and 2 wash-out months
Levels of oxidative stress in Exhaled Breath Condensate (EBC)
EBC was collected using a designated device for oxidative stress analysis.
Measured: 10 weekdays for intervention (active or sham) and 2 wash-out months
Levels of urinary metabolomics
Urine samples were collected for metabolomics analysis.
Measured: 10 weekdays for intervention (active or sham) and 2 wash-out months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start11 Dec 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furong Deng, Peking University
- Investigators
- Furong Deng, PhD&MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319056
- Sponsor's protocol ID
- FDeng17
- Status last verified
- May 2019
- First submitted
- 18 Oct 2017
- Last updated
- 23 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing
- ClinicalTrials.gov ID
- NCT03319056
- Acronym / sponsor ID
- FDeng17
- Conditions
- Cardiopulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real purification | Active comparator | Other: Air purifierAir purifier turned on |
| Sham purification | Sham comparator | Other: Air purifierAir purifier turned off |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- living in Beijing for more than two consecutive years;
- living in school dormitories from Monday to Friday.
Key exclusion criteria (2 listed)
- suffering any health condition;
- having asthma or thoracic surgery history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air purifieractive- or sham-mode air purifier used in 6 classrooms in a school with a crossover design | Other | Real purification, Sham purification |
Primary outcome
Levels of lung function indicators
Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).
5 secondary outcomes
Changes in autonomic cardiac function
Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Level of respiratory inflammation
Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Changes in ST-segment elevation
Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Levels of oxidative stress in Exhaled Breath Condensate (EBC)
Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Levels of urinary metabolomics
Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furong Deng, PhD&MD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purifier in people with Cardiopulmonary Disease, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of lung function indicators (time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.