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

Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study

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.

Study Overview

• Status: Recruiting
• Conditions: Seasonal Allergic Rhinitis; Allergic Asthma; Grass Pollen Allergy; Asthma Acute; Thunderstorm Asthma; Asthma Exacerbation Due to Thunderstorm
• Intervention / Treatment: Diagnostic test: Observational

Detailed Description

Thunderstorm asthma is a recurring public health emergency in South-Eastern Australia with increasing risks due to climate change. Yet thunderstorm asthma is only the "tip of the iceberg" of documented seasonal surges in emergency asthma presentations due to ryegrass pollen allergy - an escalating challenge to healthcare provision in South-Eastern Australia. The CARISTA (Creating A Risk assessment biomarker tool to prevent Seasonal allergic and Thunderstorm Asthma) study aims to address these profound health impacts.

The CARISTA study will recruit adults at high risk of seasonal allergic asthma and thunderstorm asthma who will be monitored using a customised secure data platform for asthma and allergic rhinitis symptoms over two consecutive spring seasons (2025/2026/2027). Participants with self-reported or diagnosed seasonal allergic rhinitis and/or seasonal allergic asthma will be recruited before springtime and their baseline allergic rhinitis and/or asthma symptoms, respiratory function and blood biomarkers (allergy or sensitisation to ryegrass pollen, levels of inflammatory cells [eosinophils]) will be measured.

The key symptoms of interest are moderate or severe asthma exacerbations which are defined as an increase in asthma symptoms requiring intervention with an emergency medical visit, use of oral corticosteroid therapy or of regular preventive asthma therapy. These asthma exacerbations will be used to establish a biomarker-based estimate of risk for seasonal allergic asthma exacerbations to inform preventive clinical practice. The key biomarker will be the threshold of serum specific IgE (sp-IgE) to ryegrass pollen and its allergen sub-components, but other biomarkers such as lung function, eosinophil levels, and allergen component sensitisation will be simultaneously assessed.

This study brings together a team of world-leading multidisciplinary and cross-sectoral clinicians and researchers in Respiratory Medicine, Allergy, Primary Health Care, Epidemiology, Public Health, Statistical modelling and Botany from multiple health and academic institutions.

Overall, CARISTA will test a new approach to predict risk for seasonal allergic asthma to identify treatable traits for preventing seasonal allergic asthma exacerbations to reduce the recurrent annual health threat of seasonal and thunderstorm asthma, address community and health care provider concerns and uncertainty regarding preventive treatment and management.

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jo A Douglass, MD; Phone Number: +6183444578; Email: jdouglass@unimelb.edu.au
• Study Contact Backup: Name: Rachel Tham, PhD; Phone Number: +61390356053; Email: CARISTA-Study@unimelb.edu.au

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Recruiting
      • Albury-Wodonga Health
      • Contact: Anna Griffith, BSc; Phone Number: +61481277942; Email: anna.griffith@awh.org.au
      • Contact: Kate Reid, RN; Phone Number: +610481277942; Email: Kathryn.reid@awh.org.au
      • Principal Investigator: Joanna Manton, MD
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Eastern Health
      • Contact: Frank Thien, MD PhD; Phone Number: +61390952415; Email: frank.thien@monash.edu
      • Contact: Claire Buchanan, RN; Phone Number: +61390952415; Email: claire.buchanan@monash.edu
    • Clayton, Victoria, Australia, 3162
      • Recruiting
      • Monash Health
      • Contact: Philip Bardin, MD PhD; Phone Number: +61395942281; Email: phil.bardin@monash.edu
      • Contact: Joanne McKenzie, RN; Phone Number: +61395942279; Email: joanne.mckenzie@monashhealth.org
      • Sub-Investigator: Laurie Ruane, BSc
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
      • Contact: Kirsty Walker, RN; Phone Number: +61394963845; Email: kirsty.walker@austin.org.au
      • Contact: Stephanie Motamedi, RN; Phone Number: +61394963845; Email: stephanie.motamedi@austin.org.au
      • Principal Investigator: Christine McDonald, MD PhD
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
      • Contact: Mark Hew, MD PhD; Phone Number: +61390762934; Email: M.hew@alfred.org.au
      • Contact: Celia Zubrinich, MD; Phone Number: +61390762934; Email: c.zubrinich@alfred.org.au
      • Sub-Investigator: Celia Zubrinich, MD
    • Parkville, Victoria, Australia, 3050
      • Recruiting
      • The Royal Melbourne Hospital
      • Contact: Rachel Tham, PhD; Phone Number: +61481058063; Email: CARISTA-study@unimelb.edu.au
      • Contact: Jo A Douglass, MD; Phone Number: Douglass 0383445479; Email: jdouglass@unimelb.edu.au
      • Principal Investigator: Jo Douglass, MD
      • Principal Investigator: Megan Rees, MD PhD
      • Sub-Investigator: Nur-shirin Harun, MD
      • Sub-Investigator: Kymble Spriggs, MD
      • Sub-Investigator: Samantha Chan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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 . -

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Observational; prospective observational cohort	Diagnostic test: Observational; Prospective observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Severe asthma exacerbations	Institution of emergency asthma treatment or medical attendance for emergency asthma treatment indicative of uncontrolled asthma or institution of oral corticosteroid therapy for asthma by a medical practitioner.	Over 13 weeks from 1 October - 31 December
Number of Participants with Onset of uncontrolled asthma	Onset of uncontrolled asthma determined by a worsening of asthma symptoms measured by the Asthma Control Questionnaire (ACQ-5:) increasing by 0.5 from baseline and being greater than 1.5. The minimum value = 0 and maximum value = 30. Higher scores indicate worse asthma symptoms.	Over 13 weeks from 1 October - 31 December

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Rhinitis symptoms	Recorded on Total Nasal Symptom Score (TNSS). The minimum value = 0 and maximum value = 9. Higher scores indicate more and worse rhinitis symptoms.	Over 13 weeks from 1 October - 31 December
Number of Participants with Hospital presentations for asthma	Hospital emergency attendance for worsening of acute asthma	Over 13 weeks from 1 October - 31 December
Number of Participants with Emergency attendance for asthma care	Emergency attendance to a clinical facility for acute asthma care	Over 13 weeks from 1 October - 31 December

Collaborators and Investigators

• Sponsor: University of Melbourne
• Collaborators: Melbourne Health; The Alfred; Queensland University of Technology; Eastern Health; Monash Medical Centre; Austin Hospital, Melbourne Australia; Northern Hospital, Australia; Western Hospital, Australia
• Investigators: Study Chair: Jo A Douglass, MD, University of Melbourne & Royal Melbourne Hospital; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 10, 2025
• First Submitted That Met QC Criteria: July 2, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: asthma; spirometry; allergy; seasonal allergic rhinitis; grass pollen allergy; hay fever; seasonal allergic rhinoconjunctivitis; ryegrass pollen; prospective symptom monitoring; serum specific IgE
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Asthma; Hypersensitivity; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: CT31402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No