Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study

NCT07055542 | Recruiting DMC

• 1 other identifier: CT31402
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 6

Brief Summary

Thunderstorm asthma is a recurring public health emergency in South-Eastern Australia which occurs in springtime. The major identified risk factors for thunderstorm asthma is hay fever and allergy to ryegrass pollen. The goal of the CARISTA study is to identify the risk of springtime allergic and thunderstorm asthma in allergic adults living in South-Eastern Australia. To do this the investigators will recruit 530 people who have hay fever and test them for allergy to ryegrass pollen and undertake simple lung function testing. The investigators will ask study participants to complete a customised symptom tracker over the springtime pollen season for 2 consecutive years. The outcome the investigators are looking for is an asthma exacerbation or worsening asthma symptoms. This study will enable the investigators to identify indicators (biomarkers) of severe and moderate asthma exacerbations in order to identify those at risk of thunderstorm and seasonal asthma so protective treatments and strategies can be advised.

Conditions

Allergic Asthma; Thunderstorm Asthma; Grass Pollen Allergy; Asthma Exacerbation Due to Thunderstorm; Asthma Acute; Seasonal Allergic Rhinitis

Keywords

asthma; allergy; grass pollen allergy; ryegrass pollen; prospective symptom monitoring; seasonal allergic rhinitis; hay fever; seasonal allergic rhinoconjunctivitis; serum specific IgE; spirometry

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Moderate or Severe Asthma Exacerbations

  Moderate and/or severe asthma exacerbations determined by * increased rescue bronchodilator medication use to a minimum of 4 puffs/day and doubling of baseline use, for 2 consecutive days * an increase in asthma symptoms requiring institution of, or doubling the regular dose of preventer asthma therapy * asthma symptoms requiring oral corticosteroid therapy * institution of emergency asthma treatment or medical attendance for emergency asthma treatment indicative of uncontrolled asthma.

  Over 13 weeks from 1 October - 31 December

Secondary Outcomes (2)

• Number of Participants with Severe asthma exacerbations

  Over 13 weeks from 1 October - 31 December

• Number of Participants with Onset of uncontrolled asthma

  Over 13 weeks from 1 October - 31 December

Other Outcomes (3)

• Number of Participants with Rhinitis symptoms

  Over 13 weeks from 1 October - 31 December

• Number of Participants with Hospital presentations for asthma

  Over 13 weeks from 1 October - 31 December

• Number of Participants with Emergency attendance for asthma care

  Over 13 weeks from 1 October - 31 December

Study Arms (1)

Observational

OTHER

prospective observational cohort

Diagnostic Test: Observational

Interventions

Observational DIAGNOSTIC_TEST

Prospective observational study

Observational

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: self-representation of gender identify
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adults aged 18 to 70 years with seasonal allergic rhinitis
• willing to undertake:
• Lung function testing
• Blood sample collection for risk factor identification, -Prospectively logging their symptoms and medications through the springtime season using the CARISTA symptom monitoring platform . -

You may not qualify if:

• Individuals unable to provide informed consent
• Individuals who do not suffer from symptoms of seasonal allergic rhinitis
• Individuals who do not consent to lung function testing and blood sample collection - Individuals with unstable asthma (FEV1 by spirometry less than 70% predicted), a recent exacerbation or change of asthma preventive medication use (within one month) would be excluded, although re-screening would be permitted after one month, time permitting.
• Individuals with severe asthma requiring the use of continuous oral corticosteroids or biological medication for severe asthma.
• The presence of any medical illness, such as cardiac disease, pre-existing illness or immunomodulatory therapy that, in the opinion of the Investigators, would compromise participant safety or the derivation of biomarkers during the study.

Sponsors & Collaborators

• University of Melbourne: lead
• The Alfred: collaborator
• Eastern Health: collaborator
• Austin Hospital, Melbourne Australia: collaborator
• Monash Medical Centre: collaborator
• Queensland University of Technology: collaborator
• Northern Hospital, Australia: collaborator
• Western Hospital, Australia: collaborator
• Melbourne Health: collaborator

Study Sites (6)

Albury-Wodonga Health

Albury, New South Wales, 2640, Australia

RECRUITING

Eastern Health

Box Hill, Victoria, 3128, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3162, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Jo A Douglass, MD

  University of Melbourne & Royal Melbourne Hospital

  STUDY CHAIR

• Phillip Bardin, MD

  Hudson Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Frank Thien, MD PhD

  Eastern Health

  PRINCIPAL INVESTIGATOR

• Mark Hew, MD PhD

  The Alfred

  PRINCIPAL INVESTIGATOR

• Janet Davies, PhD

  Queensland University of Technology

  PRINCIPAL INVESTIGATOR

• Fay Johnston, PhD

  University of Tasmania and AIRHealth PtyLtd

  PRINCIPAL INVESTIGATOR

• Edwin Lampugnani, PhD

  AirHealth Pty Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo A Douglass, MD

CONTACT

+6183444578; jdouglass@unimelb.edu.au

Rachel Tham, PhD

CONTACT

+61390356053; CARISTA-Study@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study to undertake risk prediction modelling for seasonal allergic and thunderstorm asthma

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 9, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)