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Pilot OVERNIGHT study: Assessing the efficacy of a nOVEl approach for impRoviNg symptoms in people with pre-chronic obstructive pulmonary disease usInG Hepa fiLTers

Pilot OVERNIGHT study: Assessing the efficacy of a nOVEl approach for impRoviNg symptoms in people with pre-chronic obstructive pulmonary disease usInG Hepa fiLTers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000284561
Enrollment
20
Registered
2024-03-20
Start date
2024-10-01
Completion date
2025-02-28
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic obstructive pulmonary disease (COPD) is an incurable and progressive lung disease that causes millions of deaths annually worldwide. Intervention in the pre-COPD stage (before COPD diagnosis but when lung damage has begun) may help prevent progression to COPD. Household air pollution (HAP) may worsen respiratory health. We will conduct a feasibility RCT on the use of HEPA air filters to reduce HAP for people with pre-COPD. Our results will inform future, larger research trials.

Interventions

In our proposed study, HEPA filter air purifiers will be placed in participant’s bedrooms to be used during the night over 3 months. We will use Hefil HEPA filter manufactured from Shanghai Heyi Purification Equipment Manufacuring Co. Ltd. In order to promote the adherence, we requested the modification on control panel of HEPA filter air purifiers. The machine will automatically turn on and off from 8 PM to 8 AM (overnight), and stay in sleep mode (less noises). Participants will need to provi

In our proposed study, HEPA filter air purifiers will be placed in participant’s bedrooms to be used during the night over 3 months. We will use Hefil HEPA filter manufactured from Shanghai Heyi Purification Equipment Manufacuring Co. Ltd. In order to promote the adherence, we requested the modification on control panel of HEPA filter air purifiers. The machine will automatically turn on and off from 8 PM to 8 AM (overnight), and stay in sleep mode (less noises). Participants will need to provide power only to the machine and do not need to operate. We will also provide real time air quality monitor to participants. A drop of over 60% in particulate matter (PM) levels will be defined as HEPA filter adherence amongst those with active filters. This will be assessed after study completion and unblinding. In addition, we will conduct feasibility and adherence check via online survey by sending SMS/email and after study commencement at 3, 7 and 14 days, at one month, and every month thereafter. Firstly, an SMS/email will be sent with a link. If there is no response, we will conduct telephone interviews.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Participants will be identified as having pre-COPD based on both respiratory symptoms and lower baseline lung function. Respiratory symptoms will be identified from the ECRHS IV short survey, including questions on current wheeze, current asthma, current asthma medication, current nasal allergy, chronic cough, chronic phlegm, and use of inhaled steroid medication. Lower baseline lung function will be identified as lower 50 percentile of pre-bronchodilator FEV1/FVC using GLI equation lung function reference at ECRHS IV.

Exclusion criteria

Participants do not meet the spirometric criteria for COPD (post-bronchodilator FEV1/FVC <0.7) at ECRHS IV.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026