Risk Factors for Respiratory and Cardiovascular Disease Clinical Trial
Official title:
Influence of Indoor Air Filtration Strategies on Occupant Health Indicators
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.
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai First People's Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Feng Li | Duke University, Rutgers University, Tsinghua University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | Change from baseline C-reactive protein (CRP) | 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 | No |
| Secondary | Change from baseline 8-hydroxy-2'-deoxyguanosine (8-OHdG) | 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 | No |
| Secondary | Change from baseline exhaled breath condensate malondialdehyde (EBC MDA) | 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 | No |
| Secondary | Change from baseline exhaled breath condensate nitrite + nitrate (EBCNN) | 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 | No |
| Secondary | Change from baseline exhaled breath condensate pH (EBC pH) | 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 | No |
| Secondary | Change from baseline diastolic blood pressure (DBP) | 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 | No |
| Secondary | Change from baseline forced vital capacity (FVC) | 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 | No |