Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000284561p
Ethics application status
Submitted, not yet approved
Date submitted
6/02/2024
Date registered
20/03/2024
Date last updated
20/03/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot OVERNIGHT study: Assessing the efficacy of a nOVEl approach for impRoviNg symptoms in people with pre-chronic obstructive pulmonary disease usInG Hepa fiLTers
Scientific title
Pilot OVERNIGHT study: Assessing the efficacy of a nOVEl approach for impRoviNg symptoms in people with pre-chronic obstructive pulmonary disease usInG Hepa fiLTers
Secondary ID [1] 311302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-chronic obstructive pulmonary disease 332549 0
Condition category
Condition code
Respiratory 329237 329237 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327933 0
Prevention
Comparator / control treatment
Those randomised to the control group will receive placebo filters, with the internal HEPA filter and carbon filters removed. Placebo filters will, however, run as per HEPA filters including similar noise, airflow, and appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 337318 0
Feasibility of using HEPA filter air purifiers in the designed research
Timepoint [1] 337318 0
Cumulative data will be assessed at the conclusion of recruitment.
Primary outcome [2] 337481 0
Adherence of using HEPA filter air purifiers in the designed research
Timepoint [2] 337481 0
Once we complete the recruitment, we will measure the number of participants using filters during study and barriers to filter use.
Primary outcome [3] 337482 0
Acceptance of HEPA filter of using HEPA filter air purifiers in the designed research
Timepoint [3] 337482 0
Participants' attitude to use HEPA filter at home.
Secondary outcome [1] 431425 0
Changes of respiratory symptoms
Timepoint [1] 431425 0
We will measure the score changes of SGRQ-C at baseline and 3 months post-commencement of intervention.
Secondary outcome [2] 432066 0
Sleep quality
Timepoint [2] 432066 0
We will measure the score changes of FOSQ-10 at baseline and 3 months post-commencement of intervention.
Secondary outcome [3] 432599 0
Changes of respiratory symptoms
Timepoint [3] 432599 0
We will measure score changes of RSQ at baseline, and every 4 weeks until completion of the study.

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants do not meet the spirometric criteria for COPD (post-bronchodilator FEV1/FVC <0.7) at ECRHS IV.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation list will be computer-generated by an independent statistician and carried out centrally to ensure concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who meet the inclusion criteria and consent to the proposed study will be randomised using randomly permuted blocks of varying sizes in a 1:1 ratio, stratified by smoking, atopy, and building characters. .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The analysis will include all participants according to their randomised allocation (intention-to-treat (ITT)) and reporting of the findings will follow CONSORT guidelines. Continuous data will be summarised using mean (standard deviation) or median (25th – 75th percentile), and categorical data will be summarised using frequencies and percentages. The proportion and corresponding two-sided 95% confidence intervals (CIs) calculated using the exact (Clopper-Pearson binomial) method will be presented for the primary outcomes on feasibility. Results of feasibility outcomes will be presented for all randomised patients combined. For secondary outcomes: respiratory symptoms measured using the SGRQ-C, and sleep quality measured using the FOSQ-10 score, at 3 months, will be analysed using linear regression models adjusted for baseline scores. Respiratory symptoms (RSQ) will be analysed using a constrained longitudinal data analysis (cLDA) model. The response will consist of all RSQ scores (at baseline, and every 4 weeks) and the model will include factors representing treatment, time (categorical), and treatment-by-time interaction, with the restriction of a common baseline mean across treatment groups. All analysis models for secondary outcomes will be adjusted for the stratification factors smoking, atopy status and ventilation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315556 0
University
Name [1] 315556 0
The University of Melbourne
Country [1] 315556 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 317889 0
None
Name [1] 317889 0
Address [1] 317889 0
Country [1] 317889 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314455 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 314455 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 314455 0
Australia
Date submitted for ethics approval [1] 314455 0
01/03/2024
Approval date [1] 314455 0
Ethics approval number [1] 314455 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131642 0
Dr Xin Dai
Address 131642 0
Allergy and Lung Health Unit, Centre for Epidemiology and Biostatistics, School of Population and Global Health. Level 3, 207 Bouverie Street, Carlton VIC 3053
Country 131642 0
Australia
Phone 131642 0
+61 03 83444565
Fax 131642 0
Email 131642 0
Xin.dai@unimelb.edu.au
Contact person for public queries
Name 131643 0
Xin Dai
Address 131643 0
Allergy and Lung Health Unit, Centre for Epidemiology and Biostatistics, School of Population and Global Health.Level 3, 207 Bouverie Street, Carlton VIC 3053
Country 131643 0
Australia
Phone 131643 0
+61 03 83444565
Fax 131643 0
Email 131643 0
Xin.dai@unimelb.edu.au
Contact person for scientific queries
Name 131644 0
Xin Dai
Address 131644 0
Allergy and Lung Health Unit, Centre for Epidemiology and Biostatistics, School of Population and Global Health.Level 3, 207 Bouverie Street, Carlton VIC 3053
Country 131644 0
Australia
Phone 131644 0
+61 03 83444565
Fax 131644 0
Email 131644 0
Xin.dai@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We don't plan to share our data to public. All data will be stored in secure university servers, only named university researchers (investigators) have access to these data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21582Study protocol    387146-(Uploaded-06-02-2024-15-13-51)-Study-related document.docx
21583Informed consent form    387146-(Uploaded-06-02-2024-15-14-27)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.