Risk Factors for Respiratory and Cardiovascular DiseaseNCT02769208
Influence of Indoor Air Filtration Strategies on Occupant Health Indicators
A study testing Central air handling unit air purification technologies in people with Risk Factors for Respiratory and Cardiovascular Disease, run by Feng Li at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether two different central air purification technologies reduce air pollutant exposure and beneficially influence health as evaluated with a suite of biological markers related to cardiovascular and respiratory disease risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Factors for Respiratory and Cardiovascular Disease
- What is being tested?
- Central air handling unit air purification technologies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Jan 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 adults;
- Live and work at the Broad Town work campus in eastern Changsha, Hunan Province, China
Who cannot join
- 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 study is to evaluate whether two different central air purification technologies reduce air pollutant exposure and beneficially influence health as evaluated with a suite of biological markers related to cardiovascular and respiratory disease risk.
Read the detailed description
This study will test two common types of central air handling unit filtration technologies, high-efficiency particulate air (HEPA) filters and electrostatic precipitators (ESPs), to evaluate the impacts of these technologies on personal exposure to air pollutants and the associated cardiovascular and respiratory health outcomes. HEPA filters remove a high percentage of the particulate matter in the air, as do ESPs, but ESPs also generate ozone, which may have its own detrimental health effects. These air purification technologies will be placed in different combinations with a coarse pre-filter to protect the air exchange machinery (combinations: pre-filter only, pre-filter + HEPA, and pre-filter + HEPA + ESP) in both the residences and offices of study participants living on a factory campus in Changsha, Hunan Province, China. Large dormitories and office buildings with central air handling units are common in China and around the world, and so adding air purification into the central ducts represents a practical strategy to reducing personal exposure to air pollution and related health outcomes. The Changsha area commonly suffers from high air pollution, and the dormitories and offices on this workspace are already outfitted with both HEPA filters and ESPs. Therefore, testing these technologies in this environment presents a natural experimental condition to test the benefits of air purification. The study investigators hypothesize that both the pre-filter + HEPA and pre-filter + HEPA + ESP conditions will reduce particulate matter exposure and reduce biological markers of cardiovascular and respiratory disease compared to the pre-filter alone, but that the ESP will generate enough ozone to lead to lower health benefits than HEPA+pre-filter condition.
- Being tested
- Central air handling unit air purification technologies
- Keywords
- Air Pollution, Air Filtration, Exposure Assessment, HEPA Filter, Electrostatic Precipitator, Cardiovascular Disease Biomarkers, Respiratory Disease Biomarkers
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central air handling unit air purification technologiesDevice
Also called Pre-filter, HEPA filter, Electrostatic precipitator (ESP)
As described in the arm descriptions, the interventions involve changing the baseline pre-filter + HEPA + ESP conditions by removing either just the ESP or both the ESP and the HEPA for a five week period.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Pre-Filter Only Intervention | Active comparator | Subjects in Group A start with baseline conditions of pre-filter + HEPA + ESP in their offices and dorms. After a baseline biological measurement, they then receive a 5-week intervention in which both the HEPA and ESP are removed, leaving only a pre-filter. This intervention period includes a biological measurement 2 weeks into the intervention and other 4-5 weeks into the intervention. The baseline air purification conditions are then restored, and another biological measurement is taken 2 weeks after that. Receives: Device: Central air handling unit air purification technologies |
| Group B: Pre-filter + HEPA Intervention | Active comparator | Subjects in Group B start with baseline conditions of pre-filter + HEPA + ESP in their offices and dorms. After a baseline biological measurement, they then receive a 5-week intervention in which the ESP is removed, leaving a pre-filter + HEPA combination. This intervention period includes a biological measurement 2 weeks into the intervention and other 4-5 weeks into the intervention. The baseline air purification conditions are then restored, and another biological measurement is taken 2 weeks after that. Receives: Device: Central air handling unit air purification technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline FEV1
FEV1 (forced expiratory volume in the first second of exhalation, unit: liter) was measured by spirometry in all subjects at four separate time points to compare FEV1 changes at different times before, during, and after the filtration intervention as a marker of lung function.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline soluble P-selectin
Soluble P-selectin (a protein shed by activated platelets in the blood, unit: ng/ml) was measured by ELISA in plasma in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of platelet activation.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline von Willebrand factor (VWF)
VWF (a glycoprotein released by damaged vascular cells into the blood, unit: ug/ml) was measured by ELISA in plasma in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of endothelial cell damage.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline augmentation index (AI)
AI (a measure of how much the reflecting pulse wave augments the outgoing systole pulse wave, unit: N/A (index)) was measured by pulse wave analysis in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of arterial stiffness.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline systolic blood pressure (SBP)
Brachial SBP (unit: mm Hg) was measured by an oscillometric method in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of vasoconstriction.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline fractional exhaled nitric oxide (FeNO)
FeNO (produced from inflammatory nitric oxide signalling in the lung, unit: ppb) was measured with an ambient NO-scrubbing collection method and chemiluminescence in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of airway inflammation.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Secondary outcomes (7)
Change from baseline C-reactive protein (CRP)
CRP (an inflammatory protein in the blood, unit: ng/ml) was measured with an ELISA in blood samples for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of systemic inflammation.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline 8-hydroxy-2'-deoxyguanosine (8-OHdG)
8-OHdG (a product of DNA oxidation found in the urine, unit: ng/ml) was measured with LC-MS in urine samples for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of systemic oxidative stress.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline exhaled breath condensate malondialdehyde (EBC MDA)
EBC MDA (a product of lipid oxidation found in the exhaled breath, unit: nM) was measured with HPLC in exhaled breath condensate samples for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of airway oxidative stress.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline exhaled breath condensate nitrite + nitrate (EBCNN)
EBCNN (a product of airway inflammatory NO signaling found in the exhaled breath, unit: uM) was measured with HPLC in exhaled breath condensate samples for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of airway inflammation.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline exhaled breath condensate pH (EBC pH)
EBC pH (a characteristic of exhaled breath associated with inflammation, unit: pH) was measured with a pH meter in exhaled breath condensate samples for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of airway inflammation.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline diastolic blood pressure (DBP)
DBP (unit: mm Hg) was measured with an oscillometric method for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of vasoconstriction.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline forced vital capacity (FVC)
FVC (unit: liter) was measured with spirometry for all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of airway function.
Measured: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for Respiratory and Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Li
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Tsinghua University, Rutgers University
- Responsible party
- Sponsor-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
- NCT02769208
- Sponsor's protocol ID
- 2014KY107
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Indoor Air Filtration Strategies on Occupant Health Indicators
- ClinicalTrials.gov ID
- NCT02769208
- Acronym / sponsor ID
- 2014KY107
- Keywords
- Air Pollution, Air Filtration, Exposure Assessment, HEPA Filter, Electrostatic Precipitator, Cardiovascular Disease Biomarkers, Respiratory Disease Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Feng LiUniversity, hospital or other
- Collaborators
- Duke University, Tsinghua University, Rutgers University
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 May 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 study is to evaluate whether two different central air purification technologies reduce air pollutant exposure and beneficially influence health as evaluated with a suite of biological markers related to cardiovascular and respiratory disease risk.
Detailed description
This study will test two common types of central air handling unit filtration technologies, high-efficiency particulate air (HEPA) filters and electrostatic precipitators (ESPs), to evaluate the impacts of these technologies on personal exposure to air pollutants and the associated cardiovascular and respiratory health outcomes. HEPA filters remove a high percentage of the particulate matter in the air, as do ESPs, but ESPs also generate ozone, which may have its own detrimental health effects. These air purification technologies will be placed in different combinations with a coarse pre-filter to protect the air exchange machinery (combinations: pre-filter only, pre-filter + HEPA, and pre-filter + HEPA + ESP) in both the residences and offices of study participants living on a factory campus in Changsha, Hunan Province, China. Large dormitories and office buildings with central air handling units are common in China and around the world, and so adding air purification into the central ducts represents a practical strategy to reducing personal exposure to air pollution and related health outcomes. The Changsha area commonly suffers from high air pollution, and the dormitories and offices on this workspace are already outfitted with both HEPA filters and ESPs. Therefore, testing these technologies in this environment presents a natural experimental condition to test the benefits of air purification. The study investigators hypothesize that both the pre-filter + HEPA and pre-filter + HEPA + ESP conditions will reduce particulate matter exposure and reduce biological markers of cardiovascular and respiratory disease compared to the pre-filter alone, but that the ESP will generate enough ozone to lead to lower health benefits than HEPA+pre-filter condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Pre-Filter Only Intervention | Active comparator | Device: Central air handling unit air purification technologiesSubjects in Group A start with baseline conditions of pre-filter + HEPA + ESP in their offices and dorms. After a baseline biological measurement, they then receive a 5-week intervention in which both the HEPA and ESP are removed, leaving only a pre-filter. This intervention period includes a biological measurement 2 weeks into the intervention and other 4-5 weeks into the intervention. The baseline air purification conditions are then restored, and another biological measurement is taken 2 weeks after that. |
| Group B: Pre-filter + HEPA Intervention | Active comparator | Device: Central air handling unit air purification technologiesSubjects in Group B start with baseline conditions of pre-filter + HEPA + ESP in their offices and dorms. After a baseline biological measurement, they then receive a 5-week intervention in which the ESP is removed, leaving a pre-filter + HEPA combination. This intervention period includes a biological measurement 2 weeks into the intervention and other 4-5 weeks into the intervention. The baseline air purification conditions are then restored, and another biological measurement is taken 2 weeks after that. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults;
- Live and work at the Broad Town work campus in eastern Changsha, Hunan Province, China
Key exclusion criteria (3 listed)
- 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 |
|---|---|---|
| Central air handling unit air purification technologiesAlso: Pre-filter, HEPA filter, Electrostatic precipitator (ESP)As described in the arm descriptions, the interventions involve changing the baseline pre-filter + HEPA + ESP conditions by removing either just the ESP or both the ESP and the HEPA for a five week period. | Device | Group A: Pre-Filter Only Intervention, Group B: Pre-filter + HEPA Intervention |
Primary outcome
Change from baseline FEV1
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
FEV1 (forced expiratory volume in the first second of exhalation, unit: liter) was measured by spirometry in all subjects at four separate time points to compare FEV1 changes at different times before, during, and after the filtration intervention as a marker of lung function.
Change from baseline soluble P-selectin
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Soluble P-selectin (a protein shed by activated platelets in the blood, unit: ng/ml) was measured by ELISA in plasma in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of platelet activation.
Change from baseline von Willebrand factor (VWF)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
VWF (a glycoprotein released by damaged vascular cells into the blood, unit: ug/ml) was measured by ELISA in plasma in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of endothelial cell damage.
Change from baseline augmentation index (AI)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
AI (a measure of how much the reflecting pulse wave augments the outgoing systole pulse wave, unit: N/A (index)) was measured by pulse wave analysis in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of arterial stiffness.
Change from baseline systolic blood pressure (SBP)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Brachial SBP (unit: mm Hg) was measured by an oscillometric method in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of vasoconstriction.
Change from baseline fractional exhaled nitric oxide (FeNO)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
FeNO (produced from inflammatory nitric oxide signalling in the lung, unit: ppb) was measured with an ambient NO-scrubbing collection method and chemiluminescence in all subjects at four separate time points to compare levels at different times before, during, and after the filtration intervention as a marker of airway inflammation.
7 secondary outcomes
Change from baseline C-reactive protein (CRP)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline 8-hydroxy-2'-deoxyguanosine (8-OHdG)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline exhaled breath condensate malondialdehyde (EBC MDA)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline exhaled breath condensate nitrite + nitrate (EBCNN)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline exhaled breath condensate pH (EBC pH)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline diastolic blood pressure (DBP)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Change from baseline forced vital capacity (FVC)
Time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
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 1 Jun 2016.
- 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.
Junfeng Zhang, PhD principal investigator
Duke University
Yinping Zhang, PhD principal investigator
Tsinghua 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 Central air handling unit air purification technologies in people with Risk Factors for Respiratory and Cardiovascular Disease, run by Feng Li 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 3 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 1 Jun 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 (time frame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention). The study lists 6 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 1 Jun 2016.