An interventional study of Observational in Allergic Asthma, Thunderstorm Asthma and Seasonal Allergic Rhinitis, sponsored by University of Melbourne. Recruiting at 6 sites in Australia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Melbourne · Not applicable, Interventional, and Diagnostic
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.
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.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's planned enrollment of 530 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →University of Melbourne is the lead sponsor of 86 studies on the registry; 22 are open to participants now.
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Consenting adults aged 18 to 70 years with seasonal allergic rhinitis
willing to undertake:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
prospective observational cohort
Diagnostic Test: Observational
Prospective observational study
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.
Time frame: Over 13 weeks from 1 October - 31 December
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.
Time frame: 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.
Time frame: Over 13 weeks from 1 October - 31 December
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.
Time frame: Over 13 weeks from 1 October - 31 December
Number of Participants with Hospital presentations for asthma
Hospital emergency attendance for worsening of acute asthma
Time frame: 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
Time frame: Over 13 weeks from 1 October - 31 December
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Aug 2025 (actual). Primary completion is estimated for Dec 2029, 52 months after the start.
Of 22 interventional studies with no phase under Rhinitis, Allergic, Seasonal, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 22. This study's planned 52 months is above that.
How these figures are worked out, and which studies are left out of them.
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Rhinitis, Allergic, Seasonal →
University of Melbourne