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Intervention Study on the Health Impact of Air Filters in Chinese Adults

Primary Purpose

Inflammation, Coagulation, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Air purifiers
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring air pollution, air purification, intervention, randomized controlled trial, cardiovascular health, pulmonary health

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy college students aged between 18 and 26
  • All the subjects should stay indoor almost the entire time, and stayed within the central urban area of shanghai during the wash-out period.

Exclusion Criteria:

  • current smokers or ever smokers
  • chronic respiratory diseases
  • chronic cardiovascular diseases
  • acute infections
  • medication use in recent one month

Sites / Locations

  • Department of Environmental Health, School of Public Health, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

True air purification

Sham air purification

Arm Description

One group of subjects used an intervention of true air purifiers placed in the center of the room.

This group of subjects used an intervention of sham air purifiers under the same conditions with true purifiers with the only difference being removal of the filter gauze in the sham purifiers.

Outcomes

Primary Outcome Measures

Circulating Biomarkers
Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.
Lung Function
A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.

Secondary Outcome Measures

Blood Pressure
After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.
Fractional Exhaled Nitric Oxide
FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.

Full Information

First Posted
September 7, 2014
Last Updated
January 12, 2016
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02239744
Brief Title
Intervention Study on the Health Impact of Air Filters in Chinese Adults
Official Title
Cardiopulmonary Benefits of Reducing Indoor Particles of Outdoor Origin: a Randomized Double-blind Crossover Trial of Air Purifiers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aimed to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health based on a randomized double-blind crossover trial
Detailed Description
We conducted a randomized double-blind crossover trial among 35 healthy college students in Shanghai, China in 2014. These students lived in dormitories that were randomized into two groups and alternated the use of true or sham air purifiers for 48 hours with a 2-week wash-out interval.All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period. We delivered foods and drinks to each room during the intervention period. All interventions started at 8 a.m. to avoid issues related to diurnal variation. We evaluated health endpoints and drew blood immediately after the completion of each 48-hour intervention. We measured 14 circulating biomarkers of inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and fractional exhaled nitric oxide (FeNO).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Coagulation, Blood Pressure, Pulmonary Function
Keywords
air pollution, air purification, intervention, randomized controlled trial, cardiovascular health, pulmonary health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True air purification
Arm Type
Experimental
Arm Description
One group of subjects used an intervention of true air purifiers placed in the center of the room.
Arm Title
Sham air purification
Arm Type
Sham Comparator
Arm Description
This group of subjects used an intervention of sham air purifiers under the same conditions with true purifiers with the only difference being removal of the filter gauze in the sham purifiers.
Intervention Type
Behavioral
Intervention Name(s)
Air purifiers
Other Intervention Name(s)
Air filtration
Intervention Description
The 10 dormitory rooms were randomized into two groups of 5 rooms each. One group used an air purifier placed in the center of the room for 48 hours corresponding to one weekend, followed by a 2-week washout period, and another 48 hours of using a sham air purifier under the same conditions. The other group simply reversed the order in which the real and sham air purifiers were used. All rooms used the same qualified air purifiers (model FAP04, 3M Filtrete), with the only difference being removal of the filter gauze in the sham purifiers. The air pollution auto-sensing feature of air purifiers was disabled in both groups. All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period.
Primary Outcome Measure Information:
Title
Circulating Biomarkers
Description
Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.
Time Frame
Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days
Title
Lung Function
Description
A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.
Time Frame
Within 1 hour after the end of the two-day intervention
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.
Time Frame
Within one hour after the 2-day intervention
Title
Fractional Exhaled Nitric Oxide
Description
FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.
Time Frame
within 1 hour after the two-day intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy college students aged between 18 and 26 All the subjects should stay indoor almost the entire time, and stayed within the central urban area of shanghai during the wash-out period. Exclusion Criteria: current smokers or ever smokers chronic respiratory diseases chronic cardiovascular diseases acute infections medication use in recent one month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidong Kan, PhD
Organizational Affiliation
School of Public Health,Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Environmental Health, School of Public Health, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26022815
Citation
Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.
Results Reference
derived

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Intervention Study on the Health Impact of Air Filters in Chinese Adults

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