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

INTERVENTION: 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 Smok CONDITION: Asthma;Chronic bronchitis;Emphysema;Bronchiectasis;Respiratory illness;Bush fire smoke exposure; ; Asthma ; Chronic bronchitis ; Emphysema ; Bronchiectasis ; Respiratory illness ; Bush fire smoke exposure Respiratory ‐ Asthma Respiratory ‐ Chronic obstructive pulmonary disease Respiratory ‐ Other respiratory disorders / diseases SECONDARY OUTCOME: Death (reported by participants doctor)[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.] Self reported quality of life (measured using SF1) ; [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. PRIMARY OUTCOME: 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.[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.] A self‐reported change in respiratory symptoms on a validated daily diary card[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.] 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.[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.] ; 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. ] Self‐reported adherence with allocated intervention[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.] Self‐reported adverse effects (such as skin irritation, discomfort or difficulty breathing) of the intervention, measured on the daily diary card.[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.] 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).