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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07055542
Registration number
NCT07055542
Ethics application status
Date submitted
10/06/2025
Date registered
9/07/2025
Date last updated
4/09/2025
Titles & IDs
Public title
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
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Scientific title
Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study
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Secondary ID [1]
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CT31402
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Universal Trial Number (UTN)
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Trial acronym
CARISTA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergic Asthma
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Thunderstorm Asthma
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Seasonal Allergic Rhinitis
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Grass Pollen Allergy
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Asthma Exacerbation Due to Thunderstorm
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Asthma Acute
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Allergies
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Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Observational
Other: Observational - prospective observational cohort
Diagnosis / Prognosis: Observational
Prospective observational study
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Moderate or Severe Asthma Exacerbations
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Assessment method [1]
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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.
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Timepoint [1]
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Over 13 weeks from 1 October - 31 December
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Secondary outcome [1]
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Number of Participants with Severe asthma exacerbations
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Assessment method [1]
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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.
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Timepoint [1]
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Over 13 weeks from 1 October - 31 December
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Secondary outcome [2]
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Number of Participants with Onset of uncontrolled asthma
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Assessment method [2]
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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.
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Timepoint [2]
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Over 13 weeks from 1 October - 31 December
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Eligibility
Key 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 . -
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/08/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
530
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Eastern Health
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Austin Hospital, Melbourne Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Monash Medical Centre
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Queensland University of Technology
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Northern Hospital, Australia
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Address [6]
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Country [6]
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Other collaborator category [7]
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Government body
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Name [7]
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Western Hospital, Australia
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Melbourne Health
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Address [8]
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Country [8]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07055542
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jo A Douglass, MD
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Address
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University of Melbourne & Royal Melbourne Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jo A Douglass, MD
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Address
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Country
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Phone
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+6183444578
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/42/NCT07055542/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/42/NCT07055542/Prot_SAP_000.pdf
Informed consent form
Informed Consent Form: Informed Consent
https://cdn.clinicaltrials.gov/large-docs/42/NCT07055542/ICF_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07055542
Download to PDF