NCT02769208|Completed
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Sponsor study identifier
interventional
89
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)May 10, 2016
Actual (reported)May 11, 2016
Actual (reported)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.
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.
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.
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 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 nitrite + nitrate (EBCNN)
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 201620, China
Junfeng Zhang, PhD
Duke University
Yinping Zhang, PhD
Tsinghua University
89 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2016
First Posted
May 11, 2016
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
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.
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.
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.
At baseline, 2 weeks and 4 weeks into the intervention period, and then 2 weeks post-intervention
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
June 1, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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