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

NCT02239744 | Completed Results DMC

• 1 other identifier: FDUEH-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammation; Coagulation; Blood Pressure; Pulmonary Function

Keywords

air pollution; air purification; intervention; randomized controlled trial; cardiovascular health; pulmonary health

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Blood Pressure

  Within one hour after the 2-day intervention

• Fractional Exhaled Nitric Oxide

  within 1 hour after the two-day intervention

Study Arms (2)

True air purification

EXPERIMENTAL

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

Behavioral: Air purifiers

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.

Behavioral: Air purifiers

Interventions

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.

Also known as: Air filtration

Sham air purification; True air purification

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 26022815 DERIVED

MeSH Terms

Conditions

Inflammation; Thrombosis

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Haidong Kan
• Organization: Department of Environmental Health, School of Public Health, Fudan University

kanh@fudan.edu.cn

86-21-54237908

Study Officials

• Haidong Kan, PhD

  School of Public Health，Fudan University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD and Professor

Study Record Dates

• First Submitted: September 7, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 13, 2016
• Results First Posted: December 1, 2014

Record last verified: 2016-01

Locations

CN (1)