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Air purifier and respiratory outcomes in childhood asthma in compromised housing environments: a hybrid effectiveness-implementation trial
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注册号：

Registration number：

 ChiCTR2600126785 

最近更新日期：

Date of Last Refreshed on：

 2026-06-16 09:19:06 

注册时间：

Date of Registration：

 2026-06-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Air purifier and respiratory outcomes in childhood asthma in compromised housing environments: a hybrid effectiveness-implementation trial

Public title：

Air purifier and respiratory outcomes in childhood asthma in compromised housing environments: a hybrid effectiveness-implementation trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Air purifier and respiratory outcomes in childhood asthma in compromised housing environments: a hybrid effectiveness-implementation trial

Scientific title：

Air purifier and respiratory outcomes in childhood asthma in compromised housing environments: a hybrid effectiveness-implementation trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Crystal Ying Chan 

研究负责人：

Crystal Ying Chan 

Applicant：

Crystal Ying Chan 

Study leader：

Crystal Ying Chan 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8413

研究负责人电话：

Study leader's
telephone：

+852 2252 8413

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 ychan@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 ychan@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Room 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

研究负责人通讯地址：

Room 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

Applicant address：

Room 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

Study leader's address：

Room 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025.542

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-05 00:00:00

伦理委员会联系人：

Envy lee

Contact Name of the ethic committee：

Envy lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3824

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China

Primary sponsor's address：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Jockey Club School of Public Health and Primary Care

具体地址：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China

Institution
hospital：

The Jockey Club School of Public Health and Primary Care

Address：

The Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China

经费或物资来源：

Health and Medical Research Fund (HMRF). HMRF is a Hong Kong government funding scheme administered by the Health Bureau, established to support health and medical research that addresses the needs of the Hong Kong community and contributes to the advancement of healthcare.

Source(s) of funding：

Health and Medical Research Fund (HMRF). HMRF is a Hong Kong government funding scheme administered by the Health Bureau, established to support health and medical research that addresses the needs of the Hong Kong community and contributes to the advancement of healthcare.

研究疾病：

Asthma  

Target disease：

Asthma

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Asthma is a significant public health issue, affecting approximately 300 million people globally. Due to cramped living space (with median floor area/capita of just 6m2), insufficient basic facilities (e.g., combined kitchen and toilet or sharing kitchen and toilet with multiple tenants), and poor ventilation (12.3% lack openable windows), subdivided units (SDUs) usually expose children to higher concentration of indoor air pollutants, and therefore heightened risks of developing respiratory illnesses-related healthcare use. A new wave of studies suggests that HEPA air purifiers effectively improve indoor environment, and reduce PM concentration, eventually helps improve clinical outcomes in children in terms of asthma control test scores, mean evening peak flow rates, and total nasal symptom scores when compared to sham control. However, definitive conclusions on their effectiveness for paediatric asthma remain elusive due to insufficient empirical work, methodological drawbacks inadequate blinding, and lack of real-world evidence in marginalised populations e.g. those lives in SDUs Preliminary findings from a local project conducted by our Co-A found that portable HEPA air purifier show significant improvements in indoor air quality in SDUs: PM2.5 dropped by 64.16% from 27.29 to 9.78 μg/m³, and PM10 decreased by 64.45% from 28.07 to 9.98 μg/m³. These findings led to a District Council pilot scheme in 2024, providing free air purifiers to SDU residents through Community Living Rooms (CLRs). This proposed project builds on this initiative to investigate both effectiveness and implementation outcomes for asthmatic children in HK's compromised housing environments, with potential to transform respiratory health outcomes across this underserved community.  

Objectives of Study：

Asthma is a significant public health issue, affecting approximately 300 million people globally. Due to cramped living space (with median floor area/capita of just 6m2), insufficient basic facilities (e.g., combined kitchen and toilet or sharing kitchen and toilet with multiple tenants), and poor ventilation (12.3% lack openable windows), subdivided units (SDUs) usually expose children to higher concentration of indoor air pollutants, and therefore heightened risks of developing respiratory illnesses-related healthcare use. A new wave of studies suggests that HEPA air purifiers effectively improve indoor environment, and reduce PM concentration, eventually helps improve clinical outcomes in children in terms of asthma control test scores, mean evening peak flow rates, and total nasal symptom scores when compared to sham control. However, definitive conclusions on their effectiveness for paediatric asthma remain elusive due to insufficient empirical work, methodological drawbacks inadequate blinding, and lack of real-world evidence in marginalised populations e.g. those lives in SDUs Preliminary findings from a local project conducted by our Co-A found that portable HEPA air purifier show significant improvements in indoor air quality in SDUs: PM2.5 dropped by 64.16% from 27.29 to 9.78 μg/m³, and PM10 decreased by 64.45% from 28.07 to 9.98 μg/m³. These findings led to a District Council pilot scheme in 2024, providing free air purifiers to SDU residents through Community Living Rooms (CLRs). This proposed project builds on this initiative to investigate both effectiveness and implementation outcomes for asthmatic children in HK's compromised housing environments, with potential to transform respiratory health outcomes across this underserved community.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Individuals will be excluded if they have other respiratory diseases, use steroids for non-asthma conditions, are undergoing allergen immunotherapy/asthma biological therapy, smoke, had recent asthma-related hospitalizations/A&E visits, have any serious chronic illnesses, were born before 34 weeks gestation or with birth weight <=2.5 kg, or have a congenital deformity. 2. Consent to participate was not given 3.Families who owned air cleaners, planning to move within the 28-week study duration, or those who cannot communicate in Chinese/ English 4.For families with more than one eligible child, the child with more exacerbation events in the past year will be invited to join this study (other children are excluded).

Exclusion criteria：

1. Individuals will be excluded if they have other respiratory diseases, use steroids for non-asthma conditions, are undergoing allergen immunotherapy/asthma biological therapy, smoke, had recent asthma-related hospitalizations/A&E visits, have any serious chronic illnesses, were born before 34 weeks gestation or with birth weight <=2.5 kg, or have a congenital deformity. 2. Consent to participate was not given 3.Families who owned air cleaners, planning to move within the 28-week study duration, or those who cannot communicate in Chinese/ English 4.For families with more than one eligible child, the child with more exacerbation events in the past year will be invited to join this study (other children are excluded).

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-16 00:00:00 至 To 2027-08-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 43

Group：

Intervention group

Sample size：

干预措施：

HEPA air purifier (PuraAura, HK), placed in sleeping area, operated continuously for 24 weeks

干预措施代码：

Intervention：

HEPA air purifier (PuraAura, HK), placed in sleeping area, operated continuously for 24 weeks

Intervention code：

组别：

Control group

样本量：

 43

Group：

Control group

Sample size：

干预措施：

Sham air purifier (no HEPA filtration), identical in appearance and noise, operated continuously for 24 weeks

干预措施代码：

Intervention：

Sham air purifier (no HEPA filtration), identical in appearance and noise, operated continuously for 24 weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

The rate of acute asthma attacks

指标类型：

主要指标

Outcome：

The rate of acute asthma attacks

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Exhale carbon monoxide

指标类型：

次要指标

Outcome：

Exhale carbon monoxide

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Pulmonary function

指标类型：

次要指标

Outcome：

Pulmonary function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Asthma Control

指标类型：

次要指标

Outcome：

Asthma Control

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of life of children

指标类型：

次要指标

Outcome：

Quality of life of children

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Urine metabolomics

指标类型：

次要指标

Outcome：

Urine metabolomics

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Indoor air quality

指标类型：

次要指标

Outcome：

Indoor air quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Urine

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 5 岁 years
最大 Max age 17 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Randomisation will be performed by research staff not responsible for intervention deployment or analysis, using computer-generated random sampling at a 1:1 ratio (intervention: control).

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomisation will be performed by research staff not responsible for intervention deployment or analysis, using computer-generated random sampling at a 1:1 ratio (intervention: control).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Double-blind: both participants (children and primary caregivers) and outcome-assessing research staff are blinded to group allocation. Blinding is maintained by matching the appearance and noise output of the active and sham purifiers.

Blinding：

Double-blind: both participants (children and primary caregivers) and outcome-assessing research staff are blinded to group allocation. Blinding is maintained by matching the appearance and noise output of the active and sham purifiers.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

None

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Participants will be recruited through an online questionnaire using the Qualtrics platform. The questionnaire will be distributed through various online platforms and channels, including the distribution of a text message via WhatsApp containing a link. The convenience sampling method was employed to specifically target individuals who meet the criteria for participation. Data collection and management are safeguarded by project team members and CREC.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Participants will be recruited through an online questionnaire using the Qualtrics platform. The questionnaire will be distributed through various online platforms and channels, including the distribution of a text message via WhatsApp containing a link. The convenience sampling method was employed to specifically target individuals who meet the criteria for participation. Data collection and management are safeguarded by project team members and CREC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-06-16 09:18:58
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