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临床试验/NCT05817357
NCT05817357已完成不适用

Use of Air Purification Devices in the Homes of Children and Young People to Improve Respiratory Health - a Pilot Study

University of Liverpool2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
FEV1:FVC

研究概览

简要总结

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.

详细描述

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?

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Nil specific other than not meeting inclusion criteria

结局指标

主要结局

FEV1:FVC

时间窗: 12 months

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

Asthma control test score

时间窗: 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

Number of parent/carer work days missed due to their child's asthma

时间窗: 12 months

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

Quality of life - mini paediatric asthma quality of life questionnaire score

时间窗: 12 months

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

Amount of asthma reliever medication use per week

时间窗: 12 months

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

Measurement of fraction of exhaled nitric oxide (FeNO)

时间窗: 12 months

Fraction of exhaled nitric oxide measurements

Forced expired volume in one second (FEV1)

时间窗: 12 months

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

Number of asthma exacerbations (asthma attacks)

时间窗: 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

时间窗: 12 months

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

Number of school days absent due to asthma

时间窗: 12 months

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

Forced vital capacity (FVC)

时间窗: 12 months

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

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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