Creating a risk assessment tool for thunderstorm asthma (CARISTA)
Official title: Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study
Run by University of Melbourne · NCT07055542 · Data updated 2026-11-12
This project will test whether lung tests, allergy blood markers and daily symptom tracking can predict which adults with hay fever in South‑Eastern Australia will have seasonal or thunderstorm-related asthma attacks over two spring seasons.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 530 (estimated) |
| Sponsor | University of Melbourne Academic / other |
| Locations | 6 sites (Albury, New South Wales and 5 other locations) |
| Status | Recruiting |
| Started | August 27, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT07055542 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18–70 with seasonal allergic rhinitis (hay fever) living near the listed Melbourne/Albury sites who are willing to have lung testing, give blood samples, and log symptoms during spring for two years and who do not have unstable or severe asthma requiring continuous oral steroids or biologics.
✕Probably not a fit
People without hay fever or ryegrass sensitisation, those with unstable or severe asthma on continuous oral corticosteroids or biologic therapy, or those unable/unwilling to complete lung testing, blood draws or symptom monitoring are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CARISTA will recruit adults with seasonal allergic rhinitis (hay fever) in South‑Eastern Australia and measure baseline lung function, sensitisation to ryegrass pollen, and blood inflammatory markers such as eosinophils. Participants will log symptoms and medication use through a secure customised platform across two consecutive spring pollen seasons. The study will record moderate or severe asthma exacerbations defined by emergency visits, oral steroid use, or escalation of preventive therapy. Collected clinical and biomarker data will be used to develop a risk model to identify people most likely to experience seasonal or thunderstorm asthma.
Why it matters
Potential benefit: If successful, the tool could identify people at high risk so they can get targeted prevention and treatment before high‑risk pollen seasons or storms.
How similar studies have gone: Previous observational work has shown hay fever and ryegrass sensitisation predict thunderstorm asthma risk, but biomarker-based predictive tools like this are novel and not yet validated at scale.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Albury-Wodonga Health
Albury, New South Wales, Australia Recruiting -
Eastern Health
Box Hill, Victoria, Australia Recruiting -
Monash Health
Clayton, Victoria, Australia Recruiting -
Austin Health
Heidelberg, Victoria, Australia Recruiting -
The Alfred Hospital
Melbourne, Victoria, Australia Recruiting -
The Royal Melbourne Hospital
Parkville, Victoria, Australia Recruiting
Study contacts
- Principal investigator: Phillip Bardin, MD — Hudson Institute of Medical Research
- Study coordinator: Jo A Douglass, MD
- Email: jdouglass@unimelb.edu.au
- Phone: +6183444578
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.