The Impact of Air Filtration on Asthmatic Children

NCT03282864 | Unknown

• 1 other identifier: [2016] 48
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a crossover study design to examine the impact of a two-week bedroom based indoor air filtration on the concentration of indoor airborne pollutants, personal exposure to airborne pollutants and health indicators among asthmatic children living in Shanghai, China

Conditions

Asthma in Children

Keywords

asthma; air pollution; air filtration; indoor air quality; respiratory health

Outcome Measures

Primary Outcomes (1)

• Fractional exhaled nitric oxide (FeNO)

  Fractional exhaled nitric oxide (FeNO) was measured using the NIOX machine

  Change of FeNO after the end of the two-week intervention compared to the start of the two-week intervention period

Secondary Outcomes (3)

• Asthma symptoms

  Within 24 hours before the start of intervention and within 24 hours after the end of intervention

• Peak expiratory flow (PEF)

  Measured at 7am and 9pm daily during the two-week intervention

• Lung function

  Within 24 hours before the start of intervention and within 24 hours after the end of intervention

Other Outcomes (9)

• Malondialdehyde (MDA) concentration in urine

  Within 24 hours before the start of intervention and within 24 hours after the end of intervention

• 8-OHdG concentration in urine

  Within 24 hours before the start of intervention and within 24 hours after the end of intervention

• Malondialdehyde (MDA) concentration in nasal fluid

  Within 24 hours before the start of intervention and within 24 hours after the end of intervention

Study Arms (2)

Bedroom air filtered by an air filtration device

ACTIVE COMPARATOR

The air in the bedroom of study subjects in the active comparator arm was filtered by an air filtration device which processed air through a pre-filter, a high efficiency particular air (HEPA) filter and an active carbon filter. The duration of being in the active comparator arm was 2 weeks.

Device: Bedroom air filtered by an air filtration device to remove airborne pollutants

Bedroom air filtered by a placebo air filtration device

PLACEBO COMPARATOR

The air in the bedroom of subjects in the placebo arm was filtered by a placebo air filtration device that looked identical to the real air filtration device but did not possess the HEPA filter and the active carbon filter. The duration of being in the placebo arm was 2 weeks.

Device: Bedroom air filtered by an air filtration device to remove airborne pollutants

Interventions

Bedroom air filtered by an air filtration device to remove airborne pollutants DEVICE

The air in the bedroom of study subjects in the active comparator arm was processed by an air filtration device which pulled air through a pre-filter, a high efficiency particular air (HEPA) filter and an active carbon filter continuously. The air in the bedroom of subjects in the placebo arm was processed by a placebo air filtration device that looked identical to the real air filtration device but did not possess the HEPA filter and the active carbon filter. Each subject was assigned to the active comparator arm and the placebo arm in a randomized order with a two-week washout period scheduled in-between. The subjects, their guardians and the study staff that assessed the health indicators of the subjects were blinded to this order till the end of the study.

Bedroom air filtered by a placebo air filtration device; Bedroom air filtered by an air filtration device

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• An eligible child is defined as:
• Aged between 5 and 14
• Have physician-diagnosed asthma
• Had at least one asthma attack during the past year
• An eligible household is defined as:
• Has an eligible child
• Located in Shanghai, China

You may not qualify if:

• Children who were current smokers or have diseases other than asthma are exclude from study participation

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Underwriters Laboratory, Inc: collaborator
• Duke University: collaborator
• Tsinghua University: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

Related Publications (2)

• Cui X, Li Z, Teng Y, Barkjohn KK, Norris CL, Fang L, Daniel GN, He L, Lin L, Wang Q, Day DB, Zhou X, Hong J, Gong J, Li F, Mo J, Zhang Y, Schauer JJ, Black MS, Bergin MH, Zhang J. Association Between Bedroom Particulate Matter Filtration and Changes in Airway Pathophysiology in Children With Asthma. JAMA Pediatr. 2020 Jun 1;174(6):533-542. doi: 10.1001/jamapediatrics.2020.0140.

  PMID: 32250418 DERIVED

• Brehmer C, Norris C, Barkjohn KK, Bergin MH, Zhang J, Cui X, Teng Y, Zhang Y, Black M, Li Z, Shafer MM, Schauer JJ. The impact of household air cleaners on the oxidative potential of PM2.5 and the role of metals and sources associated with indoor and outdoor exposure. Environ Res. 2020 Feb;181:108919. doi: 10.1016/j.envres.2019.108919. Epub 2019 Nov 13.

  PMID: 31753466 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael H. Bergin, PhD

  Duke University

  STUDY DIRECTOR

• Junfeng Zhang, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• James J. Schauer, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Yinping Zhang, PhD

  Tsinghua University

  PRINCIPAL INVESTIGATOR

• Feng Li, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The real air filtration device and the placebo air filtration device looked identical, however the placebo air filtration device lacked the HEPA and active carbon filters which functioned to remove airborne pollutants.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Every study subject had the air in their bedroom processed by an air filtration device (with a pre-filter, a HEPA filter and an active carbon filter) for two weeks (active comparator arm), processed by a placebo air filtration device (which did not possess the HEPA filter and active carbon filters) for two weeks (placebo arm), and underwent a two-week washout period (no use of air filtration device) between the two intervention periods.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 14, 2017
• Study Start: January 17, 2017
• Primary Completion: April 22, 2017
• Study Completion: December 1, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

CN (1)