Non-smoking, Healthy AdultsNCT02736487
Effect of Short-term Portable Air Purifier Use on Occupant Health Indicators
A study of Non-smoking, Healthy Adults, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this research project is to examine whether short-term use of portable air pollution filtration can result in changes in indoor airborne pollutants and impact on cardiovascular and respiratory health outcomes of the inhabitants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-smoking, Healthy Adults
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking adults
- Live in the dormitory building at Shanghai First People's Hospital (South Section).
Who cannot join
- Current smokers
- Has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus;
- Has any other diseases that may confound or complicate the effects of the intervention
- Pregnant females
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 201620
About this study
The purpose of this research project is to examine whether short-term use of portable air pollution filtration can result in changes in indoor airborne pollutants and impact on cardiovascular and respiratory health outcomes of the inhabitants.
Read the detailed description
This study will focus on evaluating the short-term benefits of a common portable air purifier technology in reducing air pollutant exposure and the anticipated concomitant health impacts. High ambient levels of various air pollutants in the Shanghai area serve as a useful model to test the portable air purifier intervention in a realistic setting. As most people using a portable air purifier would only be able to do so in their residences, the investigators have designed our study only to test residential air purifier use. Our hypothesis is that the reduction in pollutant concentrations in indoor air caused by the air purifier will result in measurable reductions in risk factors for cardiovascular and respiratory diseases.
- Conditions
- Non-smoking, Healthy Adults
- Being tested
- True-Washout-Sham Air Filtration Intervention, Sham-Washout-True Air Filtration Intervention
- Keywords
- Air Pollution, Exposure Assessment, Filtration, Cardiovascular Outcomes, Respiratory Outcomes, Short-term Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True-Washout-Sham Air Filtration InterventionDevice
This intervention involved three sequential steps: (1) 12 to 20 hours of true air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of sham air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.
Sham-Washout-True Air Filtration InterventionDevice
This intervention involved three sequential steps: (1) 12 to 20 hours of sham air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of true air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.
| Study group | Role | What they receive |
|---|---|---|
| Group A: True-Washout-Sham | Active comparator | Subjects in group A receives true air filtration intervention, then at least two weeks of washout period, followed by sham air filtration intervention. Receives: Device: True-Washout-Sham Air Filtration Intervention |
| Group B: Sham-Washout-True | Active comparator | Subjects in group B receives sham air filtration intervention, then at least two weeks of washout period, followed by true air filtration intervention. Receives: Device: Sham-Washout-True Air Filtration Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline FEV1 (forced expiratory volume in the first second of exhalation) within 2h after the filtration intervention
FEV1 (forced expiratory volume in the first second of exhalation, unit: liter) was measured by spirometry in all subjects within 2h after the filtration intervention to compare to FEV1 value of study subjects at baseline (i.e. at start of the study).
Measured: Within 2h after the filtration intervention
Change from baseline R5 (airway resistance measured at 5Hz) within 2h after the filtration intervention
R5 (airway resistance measured at 5Hz) was accessed by impulse oscillometry in all subjects within 2h after the filtration intervention to compare to the R5 value of study subjects at baseline (i.e. before the start of intervention).
Measured: Within 2h after the filtration intervention
Change in baseline exhaled nitric oxide (eNO) within 2h after the filtration intervention
Exhaled nitric oxide (eNO) was measured in all subjects within 2h after the filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.
Measured: Within 2h after the filtration intervention
Change in exhaled nitric oxide (eNO) at 6h after filtration intervention compared to baseline
Exhaled nitric oxide (eNO) was measured in all subjects 6h after filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.
Measured: 6h after filtration intervention
Change from baseline PWV (pulse wave velocity) within 2h after the filtration intervention
PWV (pulse wave velocity) was measured by the VICORDER instrument in all subjects right after filtration intervention to compare to the PWV value measured at baseline (i.e. before the start of intervention).
Measured: Within 2h after the filtration intervention
Secondary outcomes (6)
Change from baseline urinary biomarkers of inflammation and oxidative stress at 0h after the filtration intervention
Urine samples were collected from each subject at 0h after the filtration intervention to quantify changes in urinary oxidative stress and inflammation biomarkers compared to baseline (i.e. before intervention). The urinary biomarkers to be analyzed include: malondialdehyde (MDA), 8-hydroxy-2' -deoxyguanosine (8-OHdG) and creatinine. The unit of the urinary biomarkers will be reported as micro molar/ milliliter.
Measured: At 0h after the filtration intervention
Change in baseline urinary biomarkers of inflammation and oxidative stress at 6h after filtration intervention
Urine samples were collected from each subject at 6h after filtration intervention to quantify changes in urinary oxidative stress and inflammation biomarkers compared to baseline (i.e. before intervention). The urinary biomarkers to be analyzed include: malondialdehyde (MDA), 8-hydroxy-2' -deoxyguanosine (8-OHdG) and creatinine. The unit of the urinary biomarkers will be reported as micro molar/ milliliter.
Measured: 6h after filtration intervention
Change in baseline urinary biomarkers of inflammation and oxidative stress at 24h after filtration intervention
Urine samples were collected from each subject at 24h after filtration intervention to quantify changes in urinary oxidative stress and inflammation biomarkers compared to baseline (i.e. before intervention). The urinary biomarkers to be analyzed include: malondialdehyde (MDA), 8-hydroxy-2' -deoxyguanosine (8-OHdG) and creatinine. The unit of the urinary biomarkers will be reported as micro molar/ milliliter.
Measured: 24h after filtration intervention
Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation within 1h after filtration intervention
Blood samples were collected within 1h after filtration intervention for comparison of inflammatory and oxidative stress biomarkers to their baseline level (i.e. before the start of filtration intervention). Blood biomarkers that will be analyzed include: P-selectin, c-reactive protein, Von Willebrand factor and fibrinogen. The unit of the blood biomarkers will be reported as micro molar/ milliliter.
Measured: Within 1h after filtration intervention
Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation right after filtration intervention
Blood samples were collected 24h after filtration intervention for comparison of inflammatory and oxidative stress biomarkers to their baseline level (i.e. before the start of filtration intervention). Blood biomarkers that will be analyzed include: P-selectin, c-reactive protein, Von Willebrand factor and fibrinogen. The unit of the blood biomarkers will be reported as micro molar/ milliliter.
Measured: 24h after filtration intervention
Change in the duration of deep sleep on the first night and the second night of study participation
Duration of deep sleep was monitored by a sensor in a wristband on the first night and the second night of study participation
Measured: On the first night and the second night of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-smoking, Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Tsinghua University, Rutgers University
- Responsible party
- Principal investigator, Feng Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Junfeng Zhang, PhD, Principal investigator, Duke UniversityYinping Zhang, PhD, Principal investigator, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736487
- Sponsor's protocol ID
- 2015[38]
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Portable Air Purifier Use on Occupant Health Indicators
- ClinicalTrials.gov ID
- NCT02736487
- Acronym / sponsor ID
- 2015[38]
- Conditions
- Non-smoking, Healthy Adults
- Keywords
- Air Pollution, Exposure Assessment, Filtration, Cardiovascular Outcomes, Respiratory Outcomes, Short-term Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Duke University, Tsinghua University, Rutgers University
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Apr 2016 (estimated)
- 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 purpose of this research project is to examine whether short-term use of portable air pollution filtration can result in changes in indoor airborne pollutants and impact on cardiovascular and respiratory health outcomes of the inhabitants.
Detailed description
This study will focus on evaluating the short-term benefits of a common portable air purifier technology in reducing air pollutant exposure and the anticipated concomitant health impacts. High ambient levels of various air pollutants in the Shanghai area serve as a useful model to test the portable air purifier intervention in a realistic setting. As most people using a portable air purifier would only be able to do so in their residences, the investigators have designed our study only to test residential air purifier use. Our hypothesis is that the reduction in pollutant concentrations in indoor air caused by the air purifier will result in measurable reductions in risk factors for cardiovascular and respiratory diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: True-Washout-Sham | Active comparator | Device: True-Washout-Sham Air Filtration InterventionSubjects in group A receives true air filtration intervention, then at least two weeks of washout period, followed by sham air filtration intervention. |
| Group B: Sham-Washout-True | Active comparator | Device: Sham-Washout-True Air Filtration InterventionSubjects in group B receives sham air filtration intervention, then at least two weeks of washout period, followed by true air filtration intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, non-smoking adults
- Live in the dormitory building at Shanghai First People's Hospital (South Section).
Key exclusion criteria (4 listed)
- Current smokers
- Has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus;
- Has any other diseases that may confound or complicate the effects of the intervention
- Pregnant females
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 |
|---|---|---|
| True-Washout-Sham Air Filtration InterventionThis intervention involved three sequential steps: (1) 12 to 20 hours of true air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of sham air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented. | Device | Group A: True-Washout-Sham |
| Sham-Washout-True Air Filtration InterventionThis intervention involved three sequential steps: (1) 12 to 20 hours of sham air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of true air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented. | Device | Group B: Sham-Washout-True |
Primary outcome
Change from baseline FEV1 (forced expiratory volume in the first second of exhalation) within 2h after the filtration intervention
Time frame: Within 2h after the filtration intervention
FEV1 (forced expiratory volume in the first second of exhalation, unit: liter) was measured by spirometry in all subjects within 2h after the filtration intervention to compare to FEV1 value of study subjects at baseline (i.e. at start of the study).
Change from baseline R5 (airway resistance measured at 5Hz) within 2h after the filtration intervention
Time frame: Within 2h after the filtration intervention
R5 (airway resistance measured at 5Hz) was accessed by impulse oscillometry in all subjects within 2h after the filtration intervention to compare to the R5 value of study subjects at baseline (i.e. before the start of intervention).
Change in baseline exhaled nitric oxide (eNO) within 2h after the filtration intervention
Time frame: Within 2h after the filtration intervention
Exhaled nitric oxide (eNO) was measured in all subjects within 2h after the filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.
Change in exhaled nitric oxide (eNO) at 6h after filtration intervention compared to baseline
Time frame: 6h after filtration intervention
Exhaled nitric oxide (eNO) was measured in all subjects 6h after filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.
Change from baseline PWV (pulse wave velocity) within 2h after the filtration intervention
Time frame: Within 2h after the filtration intervention
PWV (pulse wave velocity) was measured by the VICORDER instrument in all subjects right after filtration intervention to compare to the PWV value measured at baseline (i.e. before the start of intervention).
6 secondary outcomes
Change from baseline urinary biomarkers of inflammation and oxidative stress at 0h after the filtration intervention
Time frame: At 0h after the filtration intervention
Change in baseline urinary biomarkers of inflammation and oxidative stress at 6h after filtration intervention
Time frame: 6h after filtration intervention
Change in baseline urinary biomarkers of inflammation and oxidative stress at 24h after filtration intervention
Time frame: 24h after filtration intervention
Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation within 1h after filtration intervention
Time frame: Within 1h after filtration intervention
Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation right after filtration intervention
Time frame: 24h after filtration intervention
Change in the duration of deep sleep on the first night and the second night of study participation
Time frame: On the first night and the second night of study participation
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 13 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Junfeng Zhang, PhD principal investigator
Duke University
Yinping Zhang, PhD principal investigator
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1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Non-smoking, Healthy Adults, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 4 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 13 Apr 2016. 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. 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?
Change from baseline FEV1 (forced expiratory volume in the first second of exhalation) within 2h after the filtration intervention (time frame: Within 2h after the filtration intervention). The study lists 5 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 13 Apr 2016.