Clinical trial NCT03282864: The Impact of Air Filtration on Asthmatic Children
Official title: The Impact of Air Filtration on Health Indicators of Asthmatic Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma in Children
Keywords: asthma
air pollution
air filtration
indoor air quality
respiratory health
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Underwriters Laboratory, Inc
name: Duke University
name: Tsinghua University
name: University of Wisconsin, Madison
First posted: 2017-09-14
Enrollment: 43
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: Change of FeNO after the end of the two-week intervention compared to the start of the two-week intervention period
Secondary outcomes:
measure: Asthma symptoms
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: Peak expiratory flow (PEF)
timeFrame: Measured at 7am and 9pm daily during the two-week intervention
measure: Lung function
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other outcomes:
measure: Malondialdehyde (MDA) concentration in urine
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: 8-OHdG concentration in urine
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: Malondialdehyde (MDA) concentration in nasal fluid
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: Malondialdehyde (MDA) concentration in saliva
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: Interleukin-6 level in saliva
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: Eosinophil cationic protein concentration in saliva
timeFrame: Within 24 hours before the start of intervention and within 24 hours after the end of intervention
measure: Blood eosinophil
timeFrame: Only once at the time of enrollment into the study
measure: Allergen profile
timeFrame: Only once at the time of enrollment into the study
measure: Chemical exposure
timeFrame: During 1 week of the study
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Duke University
name: Michael H. Bergin, PhD
role: STUDY_DIRECTOR
affiliation: Duke University
name: Junfeng Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: James J. Schauer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tsinghua University
name: Yinping Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Feng Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.