- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817357
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
Conditions
Intervention / Treatment
Detailed 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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L12 2AP
- Alder Hey Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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)
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.
|
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)
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
Number of work days missed due to child's asthma - assessed by questionnaire
|
12 months
|
|
Forced expired volume in one second (FEV1)
Time Frame: 12 months
|
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
|
12 months
|
|
Forced vital capacity (FVC)
Time Frame: 12 months
|
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
|
12 months
|
|
FEV1:FVC
Time Frame: 12 months
|
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
|
12 months
|
|
Measurement of fraction of exhaled nitric oxide (FeNO)
Time Frame: 12 months
|
Fraction of exhaled nitric oxide measurements
|
12 months
|
|
Acceptability to children and families participating of using an air purifier in their home
Time Frame: 12 months
|
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
Investigators
- Principal Investigator: karl A Holden, University of Liverpool
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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