Clinical trial NCT02769208: Influence of Indoor Air Filtration Strategies on Occupant Health Indicators
Official title: Influence of Indoor Air Filtration Strategies on Occupant Health Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Factors for Respiratory and Cardiovascular Disease
Keywords: Air Pollution
Air Filtration
Exposure Assessment
HEPA Filter
Electrostatic Precipitator
Cardiovascular Disease Biomarkers
Respiratory Disease Biomarkers
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Duke University
name: Tsinghua University
name: Rutgers University
First posted: 2016-05-11
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline FEV1
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline soluble P-selectin
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline von Willebrand factor (VWF)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline augmentation index (AI)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline systolic blood pressure (SBP)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline fractional exhaled nitric oxide (FeNO)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Secondary outcomes:
measure: Change from baseline C-reactive protein (CRP)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline 8-hydroxy-2'-deoxyguanosine (8-OHdG)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline exhaled breath condensate malondialdehyde (EBC MDA)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline exhaled breath condensate nitrite + nitrate (EBCNN)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline exhaled breath condensate pH (EBC pH)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline diastolic blood pressure (DBP)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
measure: Change from baseline forced vital capacity (FVC)
timeFrame: At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
affiliation: Duke University
name: Junfeng Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tsinghua University
name: Yinping Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: