【ChiCTR2600126785】Air purifier and respiratory outcomes in childhood asthma in compromised housing environments: a hybrid effectiveness-implementation trial

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基本信息

登记号

ChiCTR2600126785

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-06-16

临床申请受理号

靶点

适应症

Asthma

试验通俗题目

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

试验专业题目

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

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

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).

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.

试验项目经费来源

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.

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-06-01

试验终止时间

2028-06-30

是否属于一致性

入选标准

For Child Participant: 1. Chinese children aged 5–17 years; 2.Families residing in compromised housing conditions, e.g. SDUs lacks windows/ range hood, or using gas strove (will undergo initial screening to determine their eligibility for this study); 3. Physician-diagnosed moderate-to-severe asthma with persistent symptoms (≥two daytime episodes per week/ two nocturnal awakenings per month for a period of at least three months) in the past year, with regular use of moderate to high doses of inhaled corticosteroids or ICS/LABA combination for ≥4 weeks (NAEPP EPR-4 Step 3-4 criteria); 4. >=2 exacerbation in the past year; 5.Resident ≥5 days and nights every week in the home; 6.Can read / understand Chinese/English. For Primary caregiver (Qualitative Interview): 1.Lowest air purifier adherence at week 24; 2.Highest air purifier adherence at week 24; 3.Lowest air purifier adherence maintained at week 28; 4.Highest air purifier adherence maintained at week 28 will be recruited. For Child Participant:1. Chinese children aged 5–17 years;2.Families residing in compromised housing conditions, e.g. SDUs lacks windows/ range hood, or using gas strove (will undergo initial screening to determine their eligibility for this study);3. Physician-diagnosed moderate-to-severe asthma with persistent symptoms (≥two daytime episodes per week/ two nocturnal awakenings per month for a period of at least three months) in the past year, with regular use of moderate to high doses of inhaled corticosteroids or ICS/LABA combination for ≥4 weeks (NAEPP EPR-4 Step 3-4 criteria); 4. >=2 exacerbation in the past year; 5.Resident ≥5 days and nights every week in the home;6.Can read / understand Chinese/English.For Primary caregiver (Qualitative Interview):1.Lowest air purifier adherence at week 24; 2.Highest air purifier adherence at week 24; 3.Lowest air purifier adherence maintained at week 28;4.Highest air purifier adherence maintained at week 28 will be recruited.；

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).；

研究者信息

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试验机构

The Chinese University of Hong Kong

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