Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000801910
Ethics application status
Approved
Date submitted
16/06/2020
Date registered
10/08/2020
Date last updated
28/04/2024
Date data sharing statement initially provided
10/08/2020
Date results information initially provided
28/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Bushfire, Respiratory protection, Emphysema, bronchitis and Asthma Triggering Health Effects (BREATHE) study – evaluating the effectiveness of mask and respirator usage against respiratory symptoms in Australian adults with asthma or chronic obstructive pulmonary disease during bushfire season
Scientific title
A randomised controlled trial of of mask and respirator usage against respiratory outcomes in Australian adults with asthma or COPD during bushfire season
Secondary ID [1] 301530 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BREATHE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 317887 0
Chronic bronchitis 317888 0
Emphysema 317889 0
Bronchiectasis 317890 0
Respiratory illness 317891 0
Bush fire smoke exposure 317892 0
Condition category
Condition code
Respiratory 315928 315928 0 0
Asthma
Respiratory 315929 315929 0 0
Chronic obstructive pulmonary disease
Respiratory 316215 316215 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Consenting patients with asthma or COPD will be randomized to take one of the following three study arms when AQI is poor (> 100) or is forecast to be poor, or when a visual indication of smoke is present:
1. Wearing TGA approved surgical masks
2. Wearing TGA approved N95 respirators
3. Avoiding outdoor exposure, using guidance from NSW Health.

Participants in the intervention arms will be sent a supply of 15 masks or N95 respirators per four-week period for the follow up period by post, with instructions and a World Health Organization (WHO) video link tutorial on how to correctly wear and fit the mask. The written instructions will be existing WHO material for the surgical mask and custom instructions designed by the research team for the specific respirator used in the study. These will be delivered to the home address of the participant. When air quality is poor, participants in the intervention arms will be encouraged to use their masks or respirators when outside the home and the control arm will be encouraged to avoid outdoor air. A series of cues will be used to alert participants to potential bushfire smoke exposure as a trigger to use their intervention. During planned hazard reduction burns, participants will be notified of dates affecting their area in advance and on the day. Warnings of fires or expected fires will also be provided using data from Fire Services in NSW, Victoria, ACT and South Australia. Daily AQI readings by location from the Bureau of Meteorology will be logged and collected to correlate with outcomes and to generate SMS alerts to participants to use their allocated intervention. As some areas do not have AQI monitors, participants will also be able to use a visual assessment of smoke using the Victorian Community Smoke Standard visual air quality assessment guidelines. Briefly, this procedure provides good estimates of visibility when: It is daylight hours (avoid sunset and sunrise); the relative humidity is less than 65% because moisture in the air (fog or rain) reduces visibility; and focusing on dark objects (black is better than green).

2. Participants will be followed up for two periods: the month of April 2021, serving as self-controlled baseline period which does not include the winter influenza surge or the spring allergy season (which can both cause asthma exacerbations) and 12 weeks between August 2020 to February 2021 (planned back burning and bushfire season). Adherence will be assessed using a validated, daily diary card which participants fill in daily.

During the self-controlled periods, no intervention will be used. Participants are free to follow their normal practices and will not be stopped from using masks or N95, but will not be required to do so as part of the trial.
Intervention code [1] 317835 0
Prevention
Comparator / control treatment
Avoiding outdoor exposure. The control arm will receive information about strategies for avoiding outdoor air based on guidance from NSW Health.
The guidelines for avoiding outdoor air exposure during bushfires and dust storms for high-risk adults are available at
https://www.health.nsw.gov.au/environment/air/Pages/faqs.aspx):

As per these guidelines, when air quality is poor, participants in the control arm will be encouraged to avoid outdoor air and remain indoors with doors and windows closed. A series of cues will be used to alert participants to potential bushfire smoke exposure as a trigger to use their intervention. During planned hazard reduction burns, participants will be notified of dates affecting their area in advance and on the day. Warnings of fires or expected fires will also be provided using data from Fire Services in NSW, Victoria, ACT and South Australia. Daily AQI readings by location from the Bureau of Meteorology will be logged and collected to correlate with outcomes and to generate SMS alerts to participants to use their allocated intervention. As some areas do not have AQI monitors, participants will also be able to use a visual assessment of smoke using the Victorian Community Smoke Standard visual air quality assessment guidelines. Briefly, this procedure provides good estimates of visibility when: It is daylight hours (avoid sunset and sunrise); the relative humidity is less than 65% because moisture in the air (fog or rain) reduces visibility; and focusing on dark objects (black is better than green).

Adherence will be monitored using a validated online daily diary card with tick boxes for the mask use or environmental avoidance that will be made available to each participant in digital format. The diary card will record daily symptoms during follow up, daily use of asthma medications (preventers and relievers), other medications, GP visits and hospital presentations, exercise and adherence with mask use and environmental avoidance. The form can be completed on smart phones or computers. We have conducted multiple complex face mask and respirator trials in the past and have well developed, validated tools for diary cards, communications and follow up, which will be applied to this study.
Control group
Active

Outcomes
Primary outcome [1] 324135 0
A self-reported change in respiratory symptoms on a validated daily diary card
Timepoint [1] 324135 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment.
All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. All outcomes (and use of interventions) on a daily basis will be measured using a validated online daily diary card with tick boxes for symptoms and mask/respirator use that will be made available to each participant in digital format. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status.
Primary outcome [2] 324136 0
A self-reported change in medication use for respiratory symptoms will be documented on the online, validated daily diary card. This includes changes in maintenance inhaled therapy for asthma or COPD (inhaled corticosteroids and/or long-acting bronchodilators) or an change in use of oral corticosteroids for asthma or COPD or commencement of a course of antibiotics measured by self-report.
Timepoint [2] 324136 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment.
All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status.
Primary outcome [3] 324137 0
A self-reported presentation to the the health system (general practice or hospital) for change in respiratory symptom .will be documented on the online, validated daily diary card.
Timepoint [3] 324137 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment. All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status.
Secondary outcome [1] 383844 0
Self reported quality of life (measured using SF1)
Timepoint [1] 383844 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment.
All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status. The SF1 questionnaire will be part of a daily diary card.
Secondary outcome [2] 383845 0
Self-reported adherence with allocated intervention
Timepoint [2] 383845 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment.
All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. All outcomes will be measured using a validated online daily diary card with tick boxes for the mask/respirator use that will be made available to each participant in digital format. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status.
Secondary outcome [3] 383846 0
Death (reported by participants doctor)
Timepoint [3] 383846 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment.
All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status.
Secondary outcome [4] 384562 0
Self-reported adverse effects (such as skin irritation, discomfort or difficulty breathing) of the intervention, measured on the daily diary card.
Timepoint [4] 384562 0
All participants will be enrolled prior to the baseline data collection period, so all assessment and data collection will occur within the same dates regardless of time of enrolment.
All enrolment will occur in a four week period commencing as soon as ethics approvals are acquired (estimated late July 2020). During follow period around planned back burning from August-November 202o or during the months of December 2020 and January 2021; as well as a self-controlled period of March or April 2021, Depending on timing of any back burning activity in the August to November period, dates will vary depending on the location of participants. The December and January follow up periods are the same for all participants, and participants will be followed daily. If participants are lost to follow up or fail to return their daily diary cards, their treating doctor will be contacted to ascertain their status.

Eligibility
Key inclusion criteria
An adult 18 years of over, living in a bushfire prone area in NSW, Victoria, South Australia, Tasmania or ACT, Australia (as defined by fire services in NSW, Victoria, ACT, Tasmania and South Australia); with asthma or COPD (emphysema, chronic bronchitis, bronchiectasis).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not meeting inclusion criteria above; inability or refusal to consent; not available for follow up; age <18 years; facial hair (beard, moustache, stubble). This is because masks fit poorly over facial hair, and are ineffective.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Self-controlled period during the non-bushfire period of March-April 2021, as a time which does not coincide with bushfires or influenza season
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The RCT data will be analysed using intention to treat analysis (ITT). ITT is the appropriate analysis methodology for RCT to determine the relative efficacy of masks and N95 respirators compared to outdoor avoidance against primary and composites outcomes. The denominator will be person-days of follow-up. We will also compare outcomes of subjects in each arm with the control period of observation in March or April in a self-controlled analysis. The self-controlled analysis will compare participant symptoms and health encounters during the smoke exposure periods and the control period, to compare the rate of exacerbations of asthma/COPD during the bushfire or back-burning season with a control period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2020
Actual
2/09/2020
Date of last participant enrolment
Anticipated
30/11/2020
Actual
10/01/2024
Date of last data collection
Anticipated
30/04/2021
Actual
31/01/2024
Sample size
Target
300
Accrual to date
Final
247
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,TAS,VIC,NT,QLD,WA

Funding & Sponsors
Funding source category [1] 305969 0
Government body
Name [1] 305969 0
Medical Research Futures Fund
Country [1] 305969 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 306427 0
None
Name [1] 306427 0
Address [1] 306427 0
Country [1] 306427 0
Other collaborator category [1] 281367 0
Government body
Name [1] 281367 0
PERU, Western Sydney Local Health District
Address [1] 281367 0
Primary Health Care Education and Research Unit
Westmead Hospital
PO Box 533,
Westmead NSW 2145
NSW
Country [1] 281367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306209 0
University of New South Wales
Ethics committee address [1] 306209 0
UNSW Research Ethics
Division of Research
UNSW Sydney NSW 2052 Australia
Ethics committee country [1] 306209 0
Australia
Date submitted for ethics approval [1] 306209 0
22/06/2020
Approval date [1] 306209 0
03/08/2020
Ethics approval number [1] 306209 0
HC200477

Summary
Brief summary
The aim of this trial is to determine the impact of the use of surgical masks and P2 respirators compared to outdoor air avoidance on adverse respiratory outcomes during bushfire season in Australia.
The research questions/hypotheses that this study seeks to address are:
During or after smoke exposure does the use of masks or P2 respirators by patients with asthma and/or chronic obstructive pulmonary disease (COPD), compared with outdoor air avoidance,
1. Reduce the incidence of exacerbations?
2. Reduce respiratory symptoms?
3. Improve quality of life?
4. Cause adverse effects?
This research will provide the first clinical efficacy data on mask and respirator use for prevention of smoke-induced exacerbations of asthma and COPD in the world, and will be key to informing appropriate use of such devices for Australians affected by increased frequency of exposure to bushfires and hazardous smoke.
Trial website
https://kirby.unsw.edu.au/breathe
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103102 0
Prof Raina MacIntyre
Address 103102 0
Kirby Institute Level 6, Wallace Wurth Building,
UNSW Sydney
NSW 2052
Country 103102 0
Australia
Phone 103102 0
+61 410651612
Fax 103102 0
Email 103102 0
r.macintyre@unsw.edu.au
Contact person for public queries
Name 103103 0
Dr Aye Moa
Address 103103 0
Kirby Institute Level 6, Wallace Wurth Building,
UNSW Sydney
NSW 2052
Country 103103 0
Australia
Phone 103103 0
+61 2 9385 0938
Fax 103103 0
Email 103103 0
a.moa@unsw.edu.au
Contact person for scientific queries
Name 103104 0
Dr Aye Moa
Address 103104 0
Kirby Institute Level 6, Wallace Wurth Building,
UNSW Sydney
NSW 2052
Country 103104 0
Australia
Phone 103104 0
+61 2 9385 0938
Fax 103104 0
Email 103104 0
a.moa@unsw.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
Privacy and confidentiality and terms of consent. The narrow inclusion criteria of bushfire affected areas and asthma or COPD may make it possible to identify individuals, for example from small towns, if data are made available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo MacIntyre CR, Nguyen PY, Trent M, Seale H, Chughta... [More Details]
Other filesNo Seale H, Trent M, Marks GB, Shah S, Chughtai AA, M... [More Details]

Documents added automatically
No additional documents have been identified.