Creating a risk assessment tool for thunderstorm asthma (CARISTA)
Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 530 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Melbourne Academic / other |
| Locations | 6 sites (Albury, New South Wales and 5 other locations) |
| Trial ID | NCT07055542 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Albury, New South Wales and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.