Allergic AsthmaCARISTANCT07055542
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
A study testing Observational in people with Allergic Asthma and Thunderstorm Asthma, run by University of Melbourne at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma, Thunderstorm Asthma, Seasonal Allergic Rhinitis
- What is being tested?
- Observational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 6 sitesAustralia
- Study dates
- 27 Aug 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 . -
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Recruiting
Albury-Wodonga Health
Albury, New South Wales, 2640
Anna Griffith, BSc, +61481277942, anna.griffith@awh.org.au
Kate Reid, RN, +610481277942, Kathryn.reid@awh.org.au
- Recruiting
Eastern Health
Box Hill, Victoria, 3128
Frank Thien, MD PhD, +61390952415, frank.thien@monash.edu
Claire Buchanan, RN, +61390952415, claire.buchanan@monash.edu
- Recruiting
Monash Health
Clayton, Victoria, 3162
Philip Bardin, MD PhD, +61395942281, phil.bardin@monash.edu
Joanne McKenzie, RN, +61395942279, joanne.mckenzie@monashhealth.org
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Kirsty Walker, RN, +61394963845, kirsty.walker@austin.org.au
Stephanie Motamedi, RN, +61394963845, stephanie.motamedi@austin.org.au
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Mark Hew, MD PhD, +61390762934, M.hew@alfred.org.au
Celia Zubrinich, MD, +61390762934, c.zubrinich@alfred.org.au
- Recruiting
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Rachel Tham, PhD, +61481058063, CARISTA-study@unimelb.edu.au
Jo A Douglass, MD, 0383445479 ext. Douglass, jdouglass@unimelb.edu.au
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Asthma, Thunderstorm Asthma, Seasonal Allergic Rhinitis, Grass Pollen Allergy, Asthma Exacerbation Due to Thunderstorm, Asthma Acute
- Being tested
- Observational
- Keywords
- asthma, allergy, grass pollen allergy, ryegrass pollen, prospective symptom monitoring, seasonal allergic rhinitis, hay fever, seasonal allergic rhinoconjunctivitis, serum specific IgE, spirometry
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalDiagnostic test
Prospective observational study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Other | prospective observational cohort Receives: Diagnostic Test: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 13 weeks from 1 October - 31 December
Secondary outcomes (2)
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.
Measured: 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.
Measured: Over 13 weeks from 1 October - 31 December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start27 Aug 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study to undertake risk prediction modelling for seasonal allergic and thunderstorm asthma
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred, Eastern Health, Austin Hospital, Melbourne Australia, Monash Medical Centre, Queensland University of Technology, Northern Hospital, Australia, Western Hospital, Australia, Melbourne Health
- Responsible party
- Sponsor
- Investigators
- Jo A Douglass, MD, Study chair, University of Melbourne & Royal Melbourne HospitalPhillip Bardin, MD, Principal investigator, Hudson Institute of Medical ResearchFrank Thien, MD PhD, Principal investigator, Eastern HealthMark Hew, MD PhD, Principal investigator, The AlfredJanet Davies, PhD, Principal investigator, Queensland University of TechnologyFay Johnston, PhD, Principal investigator, University of Tasmania and AIRHealth PtyLtdEdwin Lampugnani, PhD, Principal investigator, AirHealth Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055542
- Sponsor's protocol ID
- CT31402
- Acronym
- CARISTA
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study
- ClinicalTrials.gov ID
- NCT07055542
- Acronym / sponsor ID
- CARISTA / CT31402
- Conditions
- Allergic Asthma, Thunderstorm Asthma, Seasonal Allergic Rhinitis, Grass Pollen Allergy, Asthma Exacerbation Due to Thunderstorm, Asthma Acute
- Keywords
- asthma, allergy, grass pollen allergy, ryegrass pollen, prospective symptom monitoring, seasonal allergic rhinitis, hay fever, seasonal allergic rhinoconjunctivitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- The Alfred, Eastern Health, Austin Hospital, Melbourne Australia, Monash Medical Centre, Queensland University of Technology, Northern Hospital, Australia, Western Hospital, Australia, Melbourne Health
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study to undertake risk prediction modelling for seasonal allergic and thunderstorm asthma
| Arm | Type | Receives |
|---|---|---|
| Observational | Other | Diagnostic Test: Observationalprospective observational cohort |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consenting adults aged 18 to 70 years with seasonal allergic rhinitis
- 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 . -
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalProspective observational study | Diagnostic test | Observational |
Primary outcome
Number of Participants with Moderate or Severe Asthma Exacerbations
Time frame: Over 13 weeks from 1 October - 31 December
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.
2 secondary outcomes
Number of Participants with Severe asthma exacerbations
Time frame: Over 13 weeks from 1 October - 31 December
Number of Participants with Onset of uncontrolled asthma
Time frame: Over 13 weeks from 1 October - 31 December
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jo A Douglass, MD study chair
University of Melbourne & Royal Melbourne Hospital
Phillip Bardin, MD principal investigator
Hudson Institute of Medical Research
Frank Thien, MD PhD principal investigator
Eastern Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observational in people with Allergic Asthma and Thunderstorm Asthma, run by University of Melbourne at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jo A Douglass, MD (+6183444578, jdouglass@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Moderate or Severe Asthma Exacerbations (time frame: Over 13 weeks from 1 October - 31 December). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.