ANZCTR - Registration

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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

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]

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

asthma

thunderstorm asthma

Condition category

Condition code

Respiratory

Asthma

Inflammatory and Immune System

Allergies

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

Number of asthma episodes based on patient-reported symptoms using the AirRater app during 3rd week of November 2018,

Timepoint [1]

Daily collection of symptom data from enrolment of study subject until end of study (December 9, 2018).

Secondary outcome [1]

Not applicable

Timepoint [1]

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?

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]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

The Northern Hospital - Epping

Recruitment hospital [4]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [5]

Western Hospital - Footscray - Footscray

Recruitment hospital [6]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3050 - Parkville

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3076 - Epping

Recruitment postcode(s) [4]

3084 - Heidelberg

Recruitment postcode(s) [5]

3011 - Footscray

Recruitment postcode(s) [6]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Melbourne Academic Centre for Health

Address [1]

187 Grattan Street, Carlton 3053, Victoria.

Country [1]

Australia

Primary sponsor type

Hospital

Name

Melbourne Health

Address

300 Grattan Street, Parkville 3050, VIC

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Melbourne

Address [1]

Parkville 3010, VIC

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Tasmania

Address [2]

Churchill Ave, Hobart TAS 7005

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research,
The Royal Melbourne Hospital,
Level 2 South West, 300 Grattan Street,
Parkville VIC 3050.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/09/2018

Ethics approval number [1]

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

Prof Jo Douglass

Address

Dept of Clinical Immunology and Allergy,
Royal Melbourne Hospital,
300 Grattan Street, Parkville 3050 VIC

Country

Australia

Phone

+613 9342 7191

Fax

jo.douglass@mh.org.au

Contact person for public queries

Name

Sue Schultz

Address

Dept of Clinical Immunology and Allergy,
Royal Melbourne Hospital,
300 Grattan Street, Parkville 3050 VIC

Country

Australia

Phone

+613 9342 7191

Fax

susanne.schulz@mh.org.au

Contact person for scientific queries

Name

Ju Ann Tan

Address

Dept of Clinical Immunology and Allergy,
Royal Melbourne Hospital,
300 Grattan Street, Parkville 3050 VIC

Country

Australia

Phone

+613 9342 7191

Fax

juann.tan@wh.org.au

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

Source	Title	Year of Publication	DOI
Embase	Thunderstorm asthma in seasonal allergic rhinitis: The TAISAR study.	2022	https://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.

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Documents added manually

Documents added automatically