The Impact of Air Filtration on Asthmatic Children

Asthma in Children Clinical Trial

Official title:

The Impact of Air Filtration on Health Indicators of Asthmatic Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03282864
• Other study ID #: [2016] 48
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 2020
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Duke University, Tsinghua University, Underwriters Laboratory, Inc, University of Wisconsin, Madison

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Malondialdehyde (MDA) concentration in urine	Malondialdehyde (MDA) concentration in urine was measured using the thiobarbituric acid derivatization method and high-performance liquid chromatography (HPLC)	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other	8-OHdG concentration in urine	Concentration of 8-hydroxydeoxyguanosine (8-OHdG) in urine was measured by solid phase extraction and liquid chromatography-mass spectrometry (LC-MS)	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other	Malondialdehyde (MDA) concentration in nasal fluid	Malondialdehyde (MDA) concentration in nasal fluid was measured using the thiobarbituric acid derivatization method and high-performance liquid chromatography (HPLC)	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other	Malondialdehyde (MDA) concentration in saliva	Malondialdehyde (MDA) concentration in saliva was measured using the thiobarbituric acid derivatization method and high-performance liquid chromatography (HPLC)	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other	Interleukin-6 level in saliva	The concentration of interleukin-6 in saliva was measured by enzyme-linked immunosorbent assay (ELISA)	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other	Eosinophil cationic protein concentration in saliva	The concentration of eosinophil cationic protein in saliva was measured by enzyme-linked immunosorbent assay (ELISA)	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Other	Blood eosinophil	Blood eosinophil was assessed using the blood routine test	Only once at the time of enrollment into the study
Other	Allergen profile	The IgE antibody for 19 allergens were assessed using serum samples from study subjects.	Only once at the time of enrollment into the study
Other	Chemical exposure	Personal exposure to chemicals including flame retardant and organophosphates was assessed using silicone wristbands that were worn on the wrist of study subjects for 1 week	During 1 week of the study
Primary	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	Asthma symptoms	Asthma symptom was evaluated by the Asthma Control Test (ACT) questionnaire	Within 24 hours before the start of intervention and within 24 hours after the end of intervention
Secondary	Peak expiratory flow (PEF)	The maximum speed of exhalation (PEF) was measured by a handheld PEF meter (Koka Peak Expiratory Flow Meter)	Measured at 7am and 9pm daily during the two-week intervention
Secondary	Lung function	Lung function was assessed by spirometry (Jaeger MasterScreen™ PFT system) and impulse oscillometry (Jaeger MasterScreenTM IOS).	Within 24 hours before the start of intervention and within 24 hours after the end of intervention