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This study aimed to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health based on a randomized double-blind crossover trial
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True air purification | Experimental | One group of subjects used an intervention of true air purifiers placed in the center of the room. |
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| Sham air purification | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air purifiers | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days |
| 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. | Within 1 hour after the end of the two-day intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haidong Kan, PhD | School of Public Health,Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26022815 | Derived | 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. |
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We recruited 35 healthy college students and no one were excluded according to the exclusion criteria.
We recruited 35 healthy college students.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Purifiers First, Then True Purifiers | The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers. |
| FG001 | True Purifiers First, Then Sham Purifiers | The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All 35 participants recivered palecbo and real intervention, and the order was random. This crossover study autonomically allows each subject to serve as his or her own control over time.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Purifiers | The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze. |
| BG001 | True Purifiers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We recruited all participants from the Fenglin campus of Fudan University. Therefore, all these students are young adult whose age was nearly 23 years old. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Geometric Mean | Standard Deviation | ng/ml | Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days |
|
At the end of each 2-day period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Purifiers | The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze. |
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The study only included 35 participants in 10 rooms, we might therefore have missed some potentially important but modest differences due to the relatively small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haidong Kan | Department of Environmental Health, School of Public Health, Fudan University | 86-21-54237908 | kanh@fudan.edu.cn |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D061808 | Air Filters |
| ID | Term |
|---|---|
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D004864 | Equipment and Supplies |
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|
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| Within one hour after the 2-day intervention |
| 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. | within 1 hour after the two-day intervention |
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|
The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| OG001 | True Purifiers | The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers. |
|
|
| Secondary | 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. | Posted | Geometric Mean | Standard Deviation | mmHg | Within one hour after the 2-day intervention |
|
|
|
| Primary | 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. | Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time. | Posted | Geometric Mean | Standard Deviation | L | Within 1 hour after the end of the two-day intervention |
|
|
|
| Secondary | 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. | Posted | Geometric Mean | Standard Deviation | ppb | within 1 hour after the two-day intervention |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | True Purifiers | The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers. | 0 | 35 | 0 | 35 |
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| D002318 | Cardiovascular Diseases |
| Pulse pressure |
|