ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000284561

Ethics application status

Approved

Date submitted

6/02/2024

Date registered

20/03/2024

Date last updated

6/09/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pre-chronic obstructive pulmonary disease

Condition category

Condition code

Respiratory

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]

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]

Feasibility of using HEPA filter air purifiers in the designed research

Timepoint [1]

Cumulative data will be assessed at the conclusion of recruitment.

Primary outcome [2]

Adherence of using HEPA filter air purifiers in the designed research

Timepoint [2]

Once we complete the recruitment, we will measure the number of participants using filters during study and barriers to filter use.

Primary outcome [3]

Acceptance of HEPA filter of using HEPA filter air purifiers in the designed research

Timepoint [3]

Participants' attitude to use HEPA filter at home.

Secondary outcome [1]

Changes of respiratory symptoms

Timepoint [1]

We will measure the score changes of SGRQ-C at baseline and 3 months post-commencement of intervention.

Secondary outcome [2]

Sleep quality

Timepoint [2]

We will measure the score changes of FOSQ-10 at baseline and 3 months post-commencement of intervention.

Secondary outcome [3]

Changes of respiratory symptoms

Timepoint [3]

We will measure score changes of RSQ at baseline, and every 4 weeks until completion of the study.

Secondary outcome [4]

Change of Peak Flow Rate (PFR)

Timepoint [4]

Secondary outcome [5]

Change of Peak Flow Rate (PFR)

Timepoint [5]

We will ask participants to measure the PFR at the baseline, and every month thereafter 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?

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

1/10/2024

Actual

Date of last participant enrolment

Anticipated

28/02/2025

Actual

Date of last data collection

Anticipated

30/05/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Melbourne

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Central Human Research Ethics Committee

Ethics committee address [1]

https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/08/2024

Approval date [1]

14/08/2024

Ethics approval number [1]

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

Dr Xin Dai

Address

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

Australia

Phone

+61 03 83444565

Fax

Xin.dai@unimelb.edu.au

Contact person for public queries

Name

Xin Dai

Address

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

Australia

Phone

+61 03 83444565

Fax

Xin.dai@unimelb.edu.au

Contact person for scientific queries

Name

Xin Dai

Address

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

Australia

Phone

+61 03 83444565

Fax

Xin.dai@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Attachment
21582	Study protocol	387146-(Uploaded-06-02-2024-15-13-51)-Study-related document.docx
21583	Informed consent form	387146-(Uploaded-06-02-2024-15-14-27)-Study-related document.docx
24052	Study protocol	387146-(Uploaded-30-07-2024-10-22-32)-Research Proposal_Pilot OVERNIGHT_15July.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.

Trial Review

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