Trial Outcomes & Findings for Intervention Study on the Health Impact of Air Filters in Chinese Adults (NCT NCT02239744)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days

Results posted on

2016-01-13

Participant Flow

We recruited 35 healthy college students.

We recruited 35 healthy college students and no one were excluded according to the exclusion criteria.

Participant milestones

Participant milestones
Measure	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.	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.
Period 1 STARTED	17	18
Period 1 COMPLETED	17	18
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	17	18
Period 2 COMPLETED	17	18
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Purifiers n=17 Participants 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.	True Purifiers n=18 Participants The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.	Total n=35 Participants Total of all reporting groups
Age, Continuous	24 years STANDARD_DEVIATION 2 • n=5 Participants	21 years STANDARD_DEVIATION 2 • n=7 Participants	23 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment China	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants
BMI	21 Kg/m^2 STANDARD_DEVIATION 2.5 • n=5 Participants	22 Kg/m^2 STANDARD_DEVIATION 2.5 • n=7 Participants	22 Kg/m^2 STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham Purifiers n=35 Participants 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	True Purifiers n=35 Participants The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
Circulating Biomarkers C-reaction protein（CRP）	926.3 ng/ml Standard Deviation 1967.1	913.1 ng/ml Standard Deviation 1734.0
Circulating Biomarkers Fibrinogen	1122.2 ng/ml Standard Deviation 280.1	1108.2 ng/ml Standard Deviation 232.8
Circulating Biomarkers P-selection	139.0 ng/ml Standard Deviation 41.6	129.4 ng/ml Standard Deviation 39.3
Circulating Biomarkers Soluble CD40L ligand（sCD40L）	1.4 ng/ml Standard Deviation 1.6	0.5 ng/ml Standard Deviation 1.1
Circulating Biomarkers plasminogen activator inhibitor-1（PAI-1）	54.9 ng/ml Standard Deviation 16.7	41.5 ng/ml Standard Deviation 20.0
Circulating Biomarkers Myeloperoxidase（MPO）	1579.4 ng/ml Standard Deviation 772.0	1261.4 ng/ml Standard Deviation 659.4
Circulating Biomarkers D-Dimer	1174.6 ng/ml Standard Deviation 817.2	1001.2 ng/ml Standard Deviation 988.5
Circulating Biomarkers Angiotensin-converting enzyme（ACE）	102.9 ng/ml Standard Deviation 32.4	101.1 ng/ml Standard Deviation 31.9

PRIMARY outcome

Timeframe: Within 1 hour after the end of the two-day intervention

Population: Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.

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.

Outcome measures

Outcome measures
Measure	Sham Purifiers n=35 Participants 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	True Purifiers n=35 Participants The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
Lung Function forced vital capacity(FVC)	3.0 L Standard Deviation 0.7	3.1 L Standard Deviation 0.8
Lung Function forced expiratory volume in 1 s(FEV1)	2.8 L Standard Deviation 0.5	2.8 L Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham Purifiers n=35 Participants 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	True Purifiers n=35 Participants The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
Blood Pressure Systolic pressure	106.0 mmHg Standard Deviation 9.6	103.0 mmHg Standard Deviation 10.2
Blood Pressure Diastolic pressure	70.9 mmHg Standard Deviation 8.6	67.9 mmHg Standard Deviation 8.9
Blood Pressure Pulse pressure	34.8 mmHg Standard Deviation 5.4	34.8 mmHg Standard Deviation 5.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham Purifiers n=35 Participants 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	True Purifiers n=35 Participants The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
Fractional Exhaled Nitric Oxide	14.5 ppb Standard Deviation 25.1	13.3 ppb Standard Deviation 20.6

Adverse Events

Sham Purifiers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

True Purifiers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Haidong Kan

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

Phone: 86-21-54237908

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place