Airway MorbidityNCT03788330
Short-term Health Benefits of Using Fresh Air Filtration System in Classroom
A study testing Fresh air system with filtration in people with Airway Morbidity and Cognitive and Attention Disorders and Disturbances, run by Fudan University at 1 site in China.
Trial summary
A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Morbidity, Cognitive and Attention Disorders and Disturbances, Oxidative Stress
- What is being tested?
- Fresh air system with filtration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2018to 22 Jan 2019
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All invited primary school children in Grade 5 in an artibrarily selected school
Who cannot join
- Current airway symptoms (cough, airway infection, asthma et al.)
- Acute infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools
A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.
Read the detailed description
A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. Each arm is going to be in use for five continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross over change between 3 arms is going to be taked. Then the 2nd week of intervention is performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. A total of 5 weeks is required for the project. Children's biological samples including saliva, urine and skin samples will be collected as well as exhaled NO. A questionnaire on children's perception on air quality will be assessed as well.
- Being tested
- Fresh air system with filtration
- Keywords
- exhaled nitric oxide, Sick building syndrome, indoor air
- Medical subject headings
- Cognition Disorders, Sick Building Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh air system with filtrationDevice
Also called mechanical ventilation and filtration system
Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
| Study group | Role | What they receive |
|---|---|---|
| Fresh air system with filtration | Experimental | A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom. Receives: Device: Fresh air system with filtration |
| Fresh air system with no filtration | Placebo comparator | A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom. Receives: Device: Fresh air system with filtration |
| Natural ventilation | No intervention | Natural ventilation system was applied in the 3rd classroom as normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled nitric oxide
Airway inflammation biomarker
Measured: within 2 hours of the end of intervention in each week
Oxidative stress biomarkers
The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.
Measured: within 2 hours of the end of intervention in each week
Sick building symdrom
Answering questionnaire on sick biulding symdrom
Measured: within 2 hours of the end of intervention in each week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start7 Dec 2018
- Primary completion20 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuohui Zhao, Fudan University
- Investigators
- Zhuohui Zhao, Dr, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788330
- Sponsor's protocol ID
- XFGY001
- Status last verified
- Mar 2019
- First submitted
- 5 Dec 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools
- ClinicalTrials.gov ID
- NCT03788330
- Acronym / sponsor ID
- XFGY001
- Keywords
- exhaled nitric oxide, Sick building syndrome, indoor air
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 27 Dec 2018 (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.
A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.
Detailed description
A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. Each arm is going to be in use for five continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross over change between 3 arms is going to be taked. Then the 2nd week of intervention is performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. A total of 5 weeks is required for the project. Children's biological samples including saliva, urine and skin samples will be collected as well as exhaled NO. A questionnaire on children's perception on air quality will be assessed as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fresh air system with filtration | Experimental | Device: Fresh air system with filtrationA fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom. |
| Fresh air system with no filtration | Placebo comparator | Device: Fresh air system with filtrationA fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom. |
| Natural ventilation | No intervention | –Natural ventilation system was applied in the 3rd classroom as normal. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All invited primary school children in Grade 5 in an artibrarily selected school
Key exclusion criteria (2 listed)
- Current airway symptoms (cough, airway infection, asthma et al.)
- Acute infectious diseases
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 |
|---|---|---|
| Fresh air system with filtrationAlso: mechanical ventilation and filtration systemUsing fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms | Device | Fresh air system with filtration, Fresh air system with no filtration |
Primary outcome
Exhaled nitric oxide
Time frame: within 2 hours of the end of intervention in each week
Airway inflammation biomarker
Oxidative stress biomarkers
Time frame: within 2 hours of the end of intervention in each week
The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.
Sick building symdrom
Time frame: within 2 hours of the end of intervention in each week
Answering questionnaire on sick biulding symdrom
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 29 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Zhuohui Zhao, Dr study chair
Fudan 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 Fresh air system with filtration in people with Airway Morbidity and Cognitive and Attention Disorders and Disturbances, run by Fudan 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 1 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 29 Mar 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?
Exhaled nitric oxide (time frame: within 2 hours of the end of intervention in each week). The study lists 3 primary outcomes in all. 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 29 Mar 2019.