NCT07055542 Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
| NCT ID | NCT07055542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Melbourne |
| Condition | Allergic Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 530 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 530 participants in total. It began in 2025-08-27 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Jo A Douglass, MD
STUDY CHAIR
University of Melbourne & Royal Melbourne Hospital
Frequently Asked Questions
Who can join the NCT07055542 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Allergic Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07055542 currently recruiting?
Yes, NCT07055542 is actively recruiting participants. Contact the research team at jdouglass@unimelb.edu.au for enrollment information.
Where is the NCT07055542 trial being conducted?
This trial is being conducted at Albury, Australia, Box Hill, Australia, Clayton, Australia, Heidelberg, Australia and 2 additional locations.
Who is sponsoring the NCT07055542 clinical trial?
NCT07055542 is sponsored by University of Melbourne. The principal investigator is Jo A Douglass, MD at University of Melbourne & Royal Melbourne Hospital. The trial plans to enroll 530 participants.
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