None listed
Conditions
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.
Interventions
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, wit
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed