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临床试验/NCT02769208
NCT02769208已完成不适用

Influence of Indoor Air Filtration Strategies on Occupant Health Indicators

Feng Li1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
Change from baseline soluble P-selectin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults;
  • •Live and work at the Broad Town work campus in eastern Changsha, Hunan Province, China

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Central air handling unit air purification technologies (Device)

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.

干预措施: Central air handling unit air purification technologies (Device)

结局指标

主要结局

Change from baseline soluble P-selectin

时间窗: 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 systolic blood pressure (SBP)

时间窗: 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 FEV1

时间窗: 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 von Willebrand factor (VWF)

时间窗: 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)

时间窗: 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 fractional exhaled nitric oxide (FeNO)

时间窗: 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.

次要结局

  • Change from baseline forced vital capacity (FVC)(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)(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)(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)(At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention)
  • Change from baseline diastolic blood pressure (DBP)(At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention)
  • Change from baseline C-reactive protein (CRP)(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)(At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention)

研究者

发起方
Feng Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Li

Attending Physician

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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