- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02769208
Influence of Indoor Air Filtration Strategies on Occupant Health Indicators
May 31, 2016 updated by: Feng Li
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 201620
- Shanghai First People's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults;
- Live and work at the Broad Town work campus in eastern Changsha, Hunan Province, China
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A: Pre-Filter Only Intervention
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.
|
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.
Other Names:
|
Active Comparator: Group B: Pre-filter + HEPA Intervention
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
|
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.
|
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
|
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.
|
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
|
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.
|
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
|
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.
|
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)
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.
|
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
May 10, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Estimate)
June 1, 2016
Last Update Submitted That Met QC Criteria
May 31, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014KY107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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