NCT05817357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

March 22, 2023

Last Update Submit

December 16, 2024

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (1)

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.

Device: Rensair Compact air purifier unit

Interventions

Installation of Rensair Compact air purifier (Rensair Ltd.) in the homes of children/young people participating in this study

Installation of air purifier (Rensair Ltd - Rensair Compact)

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

Study Officials

  • karl A Holden

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 18, 2023

Study Start

May 2, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations