Use of Air Purifiers to Improve Respiratory Health in Children

• Sponsor: University of Liverpool (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05817357
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Device: Rensair Compact air purifier unit	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Use of Air Purification Devices in the Homes of Children and Young People to Improve Respiratory Health - a Pilot Study
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of asthma exacerbations (asthma attacks) [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

2. Number of rescue oral steroid courses [12 months]

   Number of rescue oral steroid courses - assessed by questionnaire and prescription data

3. Quality of life - mini paediatric asthma quality of life questionnaire score [12 months]

   Quality of life using mini paediatric asthma quality of life questionnaire - the higher the score the better the quality of life

4. Asthma control test score [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

5. Amount of asthma reliever medication use per week [12 months]

   Amount of use of asthma reliever medication use over a one week period (assessed as a categorical value)

6. Number of school days absent due to asthma [12 months]

   Number of school days missed due to asthma - assessed by questionnaire

7. Number of parent/carer work days missed due to their child's asthma [12 months]

   Number of work days missed due to child's asthma - assessed by questionnaire

8. Forced expired volume in one second (FEV1) [12 months]

   Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score

9. Forced vital capacity (FVC) [12 months]

   Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score

10. FEV1:FVC [12 months]

    Spirometry measurements using ERS/ATS criteria and Global Lung Initiative Reference z-score

11. Measurement of fraction of exhaled nitric oxide (FeNO) [12 months]

    Fraction of exhaled nitric oxide measurements

12. Acceptability to children and families participating of using an air purifier in their home [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karl Holden	Liverpool	Merseyside	United Kingdom	L12 2AP

Sponsors and Collaborators

• University of Liverpool

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Liverpool
• ClinicalTrials.gov Identifier: NCT05817357
• Other Study ID Numbers: UoL001754
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 18, 2023