Asthma in ChildrenNCT05817357
Use of Air Purifiers to Improve Respiratory Health in Children
A study testing Rensair Compact air purifier unit in people with Asthma in Children, run by University of Liverpool at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Rensair Compact air purifier unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Nil specific other than not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Alder Hey Children's Hospital
Liverpool, Merseyside, L12 2AP
About this study
Official title: 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:
Read more
- 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.
Read the 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?
- Conditions
- Asthma in Children
- Being tested
- Rensair Compact air purifier unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rensair Compact air purifier unitDevice
Installation of Rensair Compact air purifier (Rensair Ltd.) in the homes of children/young people participating in this study
| Study group | Role | What they receive |
|---|---|---|
| Installation of air purifier (Rensair Ltd - Rensair Compact) | Experimental | 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. Receives: Device: Rensair Compact air purifier unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Number of rescue oral steroid courses
Number of rescue oral steroid courses - assessed by questionnaire and prescription data
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months
Number of school days absent due to asthma
Number of school days missed due to asthma - assessed by questionnaire
Measured: 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
Measured: 12 months
Forced expired volume in one second (FEV1)
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
Measured: 12 months
Forced vital capacity (FVC)
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
Measured: 12 months
FEV1:FVC
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
Measured: 12 months
Measurement of fraction of exhaled nitric oxide (FeNO)
Fraction of exhaled nitric oxide measurements
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start2 May 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- karl A Holden, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817357
- Sponsor's protocol ID
- UoL001754
- Status last verified
- Dec 2024
- First submitted
- 22 Mar 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holden KA, Hawcutt DB, Sinha IP. Installing Air Purifiers in the Homes of Children With Severe Asthma: Outcomes and Family Perspectives From a Feasibility Study. Pediatr Pulmonol. 2026 Feb;61(2):e71509. doi: 10.1002/ppul.71509.
PubMed 41705315
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Air Purification Devices in the Homes of Children and Young People to Improve Respiratory Health - a Pilot Study
- ClinicalTrials.gov ID
- NCT05817357
- Acronym / sponsor ID
- UoL001754
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Installation of air purifier (Rensair Ltd - Rensair Compact) | Experimental | Device: Rensair Compact air purifier unitRensair 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Nil specific other than not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rensair Compact air purifier unitInstallation of Rensair Compact air purifier (Rensair Ltd.) in the homes of children/young people participating in this study | Device | Installation of air purifier (Rensair Ltd - Rensair Compact) |
Primary outcome
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
Number of rescue oral steroid courses
Time frame: 12 months
Number of rescue oral steroid courses - assessed by questionnaire and prescription data
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
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
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)
Number of school days absent due to asthma
Time frame: 12 months
Number of school days missed due to asthma - assessed by questionnaire
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
Forced expired volume in one second (FEV1)
Time frame: 12 months
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
Forced vital capacity (FVC)
Time frame: 12 months
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
FEV1:FVC
Time frame: 12 months
Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score
Measurement of fraction of exhaled nitric oxide (FeNO)
Time frame: 12 months
Fraction of exhaled nitric oxide measurements
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 41705315Holden KA, Hawcutt DB, Sinha IP. Installing Air Purifiers in the Homes of Children With Severe Asthma: Outcomes and Family Perspectives From a Feasibility Study. Pediatr Pulmonol. 2026 Feb;61(2):e71509. doi: 10.1002/ppul.71509.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
karl A Holden principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rensair Compact air purifier unit in people with Asthma in Children, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of asthma exacerbations (asthma attacks) (time frame: 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.