Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001744246
Ethics application status
Approved
Date submitted
27/09/2018
Date registered
24/10/2018
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
16/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Melbourne Thunderstorm Epidemic of Asthma: Solving the Puzzle
Scientific title
TAISAR: Identifying Risks in Thunderstorm Asthma in Seasonal Allergic Rhinitis Cohort Study
Secondary ID [1] 296187 0
MH Local study no 2018.270
Universal Trial Number (UTN)
U1111-1221-2348
Trial acronym
TAISAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
allergic rhinitis 309815 0
asthma 309816 0
thunderstorm asthma 309817 0
Condition category
Condition code
Respiratory 308610 308610 0 0
Asthma
Inflammatory and Immune System 308611 308611 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
8
Target follow-up type
Weeks
Description of intervention(s) / exposure
Patients who have suffered from a thunderstorm asthma exacerbation and patients with seasonal allergic rhino-conjunctivitis are recruited into this observational study, and will be invited to a single visit at the study site collecting information on :
a) Demographic and clinical data (questionnaires, lung function tests, skin prick tests)
b) Biological samples for further analysis and biobanking (blood test)
c) Prospective data obtaining springtime symptoms of asthma and rhinitis correlated with atmospheric data (patient-reported symptoms on AirRater app). The app is downloadable onto patient's smartphone for free and once registered, patient is able to report daily symptoms of allergic rhinitis (hay fever) or asthma, medication use and location at time of symptoms is recorded through a geolocation feature within the app.

Recruitment period will be from October 15, 2018 - November 11, 2018 and the observation period will end 1st week of December (December 9, 2018).
Intervention code [1] 312512 0
Not applicable
Comparator / control treatment
We will compare those who did against those who did not suffer from thunderstorm asthma. Each study site maintains a database of patients who presented to emergency services with thunderstorm asthma on November 21, 2016 or November 16, 2017. These patients will be recruited into the historical thunderstorm asthma group. Patients with seasonal allergic rhinitis (hayfever) without thunderstorm asthma will be recruited into the control group.
Control group
Historical

Outcomes
Primary outcome [1] 307576 0
Number of asthma episodes based on patient-reported symptoms using the AirRater app during 3rd week of November 2018,
Timepoint [1] 307576 0
Daily collection of symptom data from enrolment of study subject until end of study (December 9, 2018).
Secondary outcome [1] 353204 0
Not applicable
Timepoint [1] 353204 0
Not applicable

Eligibility
Key inclusion criteria
Consenting adults aged greater than or equal to 18 years who have
a) suffered from epidemic thunderstorm asthma previously identified from hospital records
b) or individuals from similar geographic areas who suffer from seasonal allergic rhinitis who have not been identified as suffering from epidemic thunderstorm asthma.
And who are willing to participate in
a) Lung function testing
b) Sample collection for bio-banking for risk factor identification
c) and who are able to prospectively log symptom and medication through the springtime season by the use of the AirRater smartphone app.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Children <18 yrs of age
b) Individuals unable to provide informed consent
c) Individuals who do not suffer from symptoms of seasonal allergic rhinoconjunctivitis
d) Individuals who do not consent to the conduct of lung function testing and biological sample collection

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
A sample size of 400 has been estimated for recruitment for this study over all study sites. This is based on the likely available resources and patient numbers already identified from the 2016 epidemic and equal numbers of seasonal allergic rhinitis participants. This sample size will enable the detection of an outcome relative risk of 2 in th cases with 90% power and 5% significance.

Descriptive statistics will be conducted on the clinical and biological data for the cohort as a whole, including means and standard deviations, medians and interquartile ranges.

Comparative statistics to determine differences between cases (those who had thunderstorm asthma) and controls (those who did not) will be calculated with t-tests and chi2 tests. We will perform regression analysis comparing thunderstorm asthma group versus seasonal allergic rhino-conjunctivitis only to determine a predictive model for risk of thunderstorm asthma amongst seasonal allergic rhino-conjunctivitis sufferers. Potential confounders and effect modifiers will be identified.

Using the AirRater App, prospectively collected symptom and medication data will be correlated with air quality, pollen counts, meterological data, demographic data, clinical data, and environmental risk factors.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/10/2018
Date of last participant enrolment
Anticipated
11/11/2018
Actual
18/12/2018
Date of last data collection
Anticipated
9/12/2018
Actual
31/12/2018
Sample size
Target
400
Accrual to date
Final
227
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12020 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 12021 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 12022 0
The Northern Hospital - Epping
Recruitment hospital [4] 12023 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 12024 0
Western Hospital - Footscray - Footscray
Recruitment hospital [6] 12025 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 24171 0
3050 - Parkville
Recruitment postcode(s) [2] 24172 0
3168 - Clayton
Recruitment postcode(s) [3] 24173 0
3076 - Epping
Recruitment postcode(s) [4] 24174 0
3084 - Heidelberg
Recruitment postcode(s) [5] 24175 0
3011 - Footscray
Recruitment postcode(s) [6] 24176 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 300777 0
Other Collaborative groups
Name [1] 300777 0
Melbourne Academic Centre for Health
Country [1] 300777 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
300 Grattan Street, Parkville 3050, VIC
Country
Australia
Secondary sponsor category [1] 300321 0
None
Name [1] 300321 0
Address [1] 300321 0
Country [1] 300321 0
Other collaborator category [1] 280365 0
University
Name [1] 280365 0
University of Melbourne
Address [1] 280365 0
Parkville 3010, VIC
Country [1] 280365 0
Australia
Other collaborator category [2] 280366 0
University
Name [2] 280366 0
University of Tasmania
Address [2] 280366 0
Churchill Ave, Hobart TAS 7005
Country [2] 280366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301559 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 301559 0
Office for Research,
The Royal Melbourne Hospital,
Level 2 South West, 300 Grattan Street,
Parkville VIC 3050.
Ethics committee country [1] 301559 0
Australia
Date submitted for ethics approval [1] 301559 0
Approval date [1] 301559 0
14/09/2018
Ethics approval number [1] 301559 0
HREC/43014/MH-2018-67637

Summary
Brief summary
On 21st November 2016, Melbourne suffered an asthma epidemic following a thunderstorm that overwhelmed emergency services and led to the activation of disaster codes. Tragically, 10 people died of asthma as a consequence. Whilst clusters of Epidemic Thunderstorm Asthma (ETSA) have been previously reported, this event was unprecedented in its severity. It is inevitable that such severe weather events as occurred in 2016 will recur, so that the risks to individuals need to be better understood and preventive strategies developed based on evidence that can apply at both an individual, clinical and at a public health level. So there is an urgent need to identify predictors of susceptibility and severity to ETSA to inform public health and clinical preventive strategies.
This proposal brings together a team of clinicians, epidemiologists, botanists, medical, pharmaceutical, scientific and policy experts to answer questions resulting from this epidemic and provide evidence-based advice to the community and health care providers to manage recurrent weather events of this nature. The study is planned to begin immediately prior to the 2018-9 grass pollen season and recruit people from October 2018. Participants will form a cohort that can be monitored with an App for the upcoming season. The project findings will be disseminated through the scientific literature but will also be disseminated through peak asthma bodies and clinical guidelines as well as public health initiatives.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87386 0
Prof Jo Douglass
Address 87386 0
Dept of Clinical Immunology and Allergy,
Royal Melbourne Hospital,
300 Grattan Street, Parkville 3050 VIC
Country 87386 0
Australia
Phone 87386 0
+613 9342 7191
Fax 87386 0
Email 87386 0
[email protected]
Contact person for public queries
Name 87387 0
Ms Sue Schultz
Address 87387 0
Dept of Clinical Immunology and Allergy,
Royal Melbourne Hospital,
300 Grattan Street, Parkville 3050 VIC
Country 87387 0
Australia
Phone 87387 0
+613 9342 7191
Fax 87387 0
Email 87387 0
[email protected]
Contact person for scientific queries
Name 87388 0
Dr Ju Ann Tan
Address 87388 0
Dept of Clinical Immunology and Allergy,
Royal Melbourne Hospital,
300 Grattan Street, Parkville 3050 VIC
Country 87388 0
Australia
Phone 87388 0
+613 9342 7191
Fax 87388 0
Email 87388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified partipant responses on questionnaires and patient reported symptoms on AirRater app
When will data be available (start and end dates)?
1 January 2019 - 30 June 2019
Available to whom?
Collaborators from School of Public Health, University of Melbourne (Prof. S. Dharmage and Dr C. Lodge)
Available for what types of analyses?
Statistical analysis including descriptive, comparison and regression analysis.
How or where can data be obtained?
Deidentified information will be available on excel spreadsheet (electronic format).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThunderstorm asthma in seasonal allergic rhinitis: The TAISAR study.2022https://dx.doi.org/10.1016/j.jaci.2021.10.028
N.B. These documents automatically identified may not have been verified by the study sponsor.