- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02239744
Intervention Study on the Health Impact of Air Filters in Chinese Adults
January 12, 2016 updated by: Haidong Kan, Fudan University
Cardiopulmonary Benefits of Reducing Indoor Particles of Outdoor Origin: a Randomized Double-blind Crossover Trial of Air Purifiers
This study aimed to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health based on a randomized double-blind crossover trial
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Department of Environmental Health, School of Public Health, Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 26 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: True air purification
One group of subjects used an intervention of true air purifiers placed in the center of the room.
|
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.
Other Names:
|
Sham Comparator: Sham air purification
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating Biomarkers
Time Frame: Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days
|
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.
|
Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days
|
Lung Function
Time Frame: Within 1 hour after the end of the two-day intervention
|
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.
|
Within 1 hour after the end of the two-day intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: Within one hour after the 2-day intervention
|
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.
|
Within one hour after the 2-day intervention
|
Fractional Exhaled Nitric Oxide
Time Frame: within 1 hour after the two-day intervention
|
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.
|
within 1 hour after the two-day intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Haidong Kan, PhD, School of Public Health,Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 7, 2014
First Submitted That Met QC Criteria
September 11, 2014
First Posted (Estimate)
September 15, 2014
Study Record Updates
Last Update Posted (Estimate)
January 13, 2016
Last Update Submitted That Met QC Criteria
January 12, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDUEH-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Assistance Publique - Hôpitaux de ParisCompletedDigestive InflammationFrance
-
Pamukkale UniversityCompletedPeriodontal InflammationTurkey
-
Universidade Federal do ParaCompleted
-
KLE Society's Institute of Dental SciencesCompletedRegenerative InflammationIndia
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Oral Science International Inc.AdvarraNot yet recruiting
Clinical Trials on Air purifiers
-
Tiantian LiCompletedProtective Effect of Air Purifier on Children's HealthChina
-
Norwegian Institute of Public HealthSINTEF Health ResearchActive, not recruitingFeasibility | AcceptabilityNorway
-
Fudan UniversityCompleted
-
University of MichiganNational Institute of Nursing Research (NINR); Michigan State UniversityRecruitingCardiometabolic HealthUnited States
-
AlyatecCompletedAsthma | AllergyFrance
-
Assistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseTerminated
-
University of MichiganJRD Enterprises LLC; Michigan Corporate Relations Network Small Company Innovation...CompletedStroke | Spinal Cord Injuries | Healthy AdultsUnited States
-
Fudan UniversityRecruiting
-
Beth Israel Deaconess Medical CenterNational Institute of Environmental Health Sciences (NIEHS)Enrolling by invitation
-
University of MichiganNational Institute of Environmental Health Sciences (NIEHS)Completed