Use of Air Purifiers to Improve Respiratory Health in Children

Use of Air Purification Devices in the Homes of Children and Young People to Improve Respiratory Health - a Pilot Study

The goal of this pilot study is to investigate if installing an air purifier in the homes of children and young people with asthma improves their asthma outcomes.

The main questions it aims to answer are:

• Does installing an air purifier in the homes of children and young people with asthma improve their asthma outcomes
• Is the use of an air purifier in the home acceptable to children and young people and their families?

Children and young people with asthma attending our clinic will be selected at random to be invited to take part. For those that take part, an air purifier (Rensair Ltd. - Rensair Compact) will be installed in their home for a one-year period. Data will be collected on numbers of asthma attacks, rescue oral steroids, quality of life, symptoms, lung function at the beginning and at three-monthly intervals throughout the study period. The acceptability to children and young people and their families taking part in this study of using an air purifier in their home will also be assessed.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Device: Rensair Compact air purifier unit

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl A Holden; Phone Number: +441512284811; Email: karl.holden@liverpool.ac.uk

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L12 2AP
      • Karl Holden
      • Contact: Karl A Holden; Email: karl.holden@liverpool.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 5 to 15 years old
• Attend the asthma clinic in our hospital
• Have a confirmed physician-diagnosis of asthma from the asthma clinic
• Live in mainland England (this is due to delivery of the air purification units and also associated maintenance of them)

Exclusion Criteria:

• Nil specific other than not meeting inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Installation of air purifier (Rensair Ltd - Rensair Compact); Rensair Compact air purifier unit will be installed in the homes of all children/young people participating in this study for a period of one-year.	Device: Rensair Compact air purifier unit; Installation of Rensair Compact air purifier (Rensair Ltd.) in the homes of children/young people participating in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of asthma exacerbations (asthma attacks)	Asthma attacks and unscheduled healthcare visits due to acute asthma (including ED attendance, admission, GP/primary care attendance) - assessed by questionnaire and hospital-recorded attendances/admissions	12 months
Number of rescue oral steroid courses	Number of rescue oral steroid courses - assessed by questionnaire and prescription data	12 months
Quality of life - mini paediatric asthma quality of life questionnaire score	Quality of life using mini paediatric asthma quality of life questionnaire - the higher the score the better the quality of life	12 months
Asthma control test score	Asthma control test (ACT) or child asthma control test score (cACT) - depending on age of participant - the higher the score the better the asthma control	12 months
Amount of asthma reliever medication use per week	Amount of use of asthma reliever medication use over a one week period (assessed as a categorical value)	12 months
Number of school days absent due to asthma	Number of school days missed due to asthma - assessed by questionnaire	12 months
Number of parent/carer work days missed due to their child's asthma	Number of work days missed due to child's asthma - assessed by questionnaire	12 months
Forced expired volume in one second (FEV1)	Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score	12 months
Forced vital capacity (FVC)	Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score	12 months
FEV1:FVC	Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score	12 months
Measurement of fraction of exhaled nitric oxide (FeNO)	Fraction of exhaled nitric oxide measurements	12 months
Acceptability to children and families participating of using an air purifier in their home	Acceptability to children and young people and their families taking part in the study in terms of use of air purifier in their homes - assessed by questionnaire	12 months

Collaborators and Investigators

• Sponsor: University of Liverpool

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: UoL001754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No