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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05817357
Other study ID # UoL001754
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2, 2023
Est. completion date July 30, 2024

Study information

Verified date June 2023
Source University of Liverpool
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 (including reduction in asthma exacerbations, improvement in symptom control, improvement in quality of life). - Is the use of an air purifier in the home acceptable to children and young people and their families?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Alder Hey Children's Hospital Liverpool Merseyside

Sponsors (1)

Lead Sponsor Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Number of rescue oral steroid courses Number of rescue oral steroid courses - assessed by questionnaire and prescription data 12 months
Primary 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
Primary 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
Primary 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
Primary Number of school days absent due to asthma Number of school days missed due to asthma - assessed by questionnaire 12 months
Primary 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
Primary Forced expired volume in one second (FEV1) Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score 12 months
Primary Forced vital capacity (FVC) Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score 12 months
Primary FEV1:FVC Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score 12 months
Primary Measurement of fraction of exhaled nitric oxide (FeNO) Fraction of exhaled nitric oxide measurements 12 months
Primary 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
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