The Impact of Air Filtration on Asthmatic Children

NCT ID: NCT03282864

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2020-12-31

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

Detailed Description

This study recruited asthmatic children aged 5 to 14 who were living in Shanghai, China. 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. The doors and windows of the bedroom were instructed to be kept closed during the intervention periods. The sequence of being in the active comparator arm and the placebo arm was randomized for each subject. The subject, their guardian and researchers who have direct interaction with the study subjects do not know this sequence until after the end of the study.

The study protocol was approved by IRB at Shanghai First People's Hospital, Duke University and University of Wisconsin at Madison. A sample size of 40 was calculated using fractional exhaled nitric oxide (FeNO) as the primary outcome where statistical significance was set at 0.05, power at 90%, and between-subject variance and covariance were estimated from existing literature. Four additional subjects were added to the estimated sample size of 40 to account for potential dropouts. Subjects were recruited from patients who attended the outpatient clinic of the Pediatrics Department of Shanghai First People's Hospital (south section) by Dr. Zhen Li and Dr. Junfeng Zhang's team. Assent was obtained from all study subjects and written informed consent was obtained from their guardians.

During the study, Dr. Michael Bergin's team and Dr. Yinping Zhang's team installed the air filtration devices in the subject's bedroom and measured the indoor concentration, outdoor concentration and personal exposure to airborne pollutants including PM2.5, ozone and volatile organic compounds. Dr. James Schauer's team analyzed the physical, chemical and bioactivity of the airborne particles collected and had no direct contact with the study subjects.

Each subject attended 5 clinical visits at the Shanghai First People's Hospital (South Section) accompanied by their guardian where clinical assessment (of lung function, fractional exhaled nitric oxide, asthma symptom blood draw) was performed by Drs. Zhen Li and Feng Li's team, and the collection of biological media (urine, saliva and nasal fluid) was conducted by Dr. Junfeng (Jim) Zhang's team. In addition, subjects were instructed to measure the peak expiratory flow (PEF) at 7am and 9pm daily and recorded their asthma symptoms at home with the assistance from their guardian(s). The biological media (urine, saliva and nasal fluid) collected was subsequently analyzed by Dr. Junfeng (Jim) Zhang's team for health indicators.

Each subject had access to the result of clinical assessment and health indicator in biological media, as well as free consultation from the medical teams of Drs. Zhen Li and Feng Li. Every subject was remunerated with 1000RMB (equivalent to 152 US dollars) and given a peak expiratory flow meter (worth less than 10 US dollars). All information collected from study subjects were recorded under their subject ID number and kept confidential. Only de-identified data was shared between collaborating investigators. Statistical analysis including mixed-effects models will be conducted on the data collected.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bedroom air filtered by an air filtration device

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Underwriters Laboratory, Inc

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Tsinghua University

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Zhen Li

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael H. Bergin, PhD

Role: STUDY_DIRECTOR

Duke University

Junfeng Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

James J. Schauer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Yinping Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tsinghua University

Feng Li, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32250418 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31753466 (View on PubMed)

Other Identifiers

[2016] 48

Identifier Type: -

Identifier Source: org_study_id