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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201620
        • Shanghai First People's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Central air handling unit air purification technologies
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:
  • Pre-filter
  • HEPA filter
  • Electrostatic precipitator (ESP)
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.
Device: Central air handling unit air purification technologies
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:
  • Pre-filter
  • HEPA filter
  • Electrostatic precipitator (ESP)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Feng Li

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
Rutgers University
Tsinghua University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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