Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID07055542

Creating A Risk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study

Led by University of Melbourne · Updated on 2026-05-06

530

Participants Needed

6

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Melbourne

Lead Sponsor

T

The Alfred

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating thunderstorm asthma and seasonal allergic asthma in adults with hay fever living in South-Eastern Australia, where thunderstorm asthma is a recurring health emergency in spring caused mainly by ryegrass pollen allergy. The CARISTA study aims to identify risk factors and biomarkers for asthma exacerbations triggered by these seasonal allergies to help improve preventive care. The study will recruit 530 adults aged 18 to 70 years who have seasonal allergic rhinitis. Participants will undergo lung function tests and blood sample collection to measure allergy markers, including ryegrass pollen-specific IgE and inflammatory cells. They will use a secure symptom monitoring platform to log symptoms and medication use during two consecutive spring seasons from October to December. Participants will be monitored for moderate or severe asthma exacerbations, defined by emergency visits or need for corticosteroid therapy, over 13 weeks each spring season. Researchers will assess lung function, blood biomarkers, and symptom reports to identify indicators of asthma worsening and risk for thunderstorm asthma. The study includes regular assessments and aims to develop a biomarker-based risk tool for better prevention strategies.

CONDITIONS

Brief Title

Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years with seasonal allergic rhinitis
  • Willing to undergo lung function testing
  • Willing to provide blood samples for risk factor identification
  • Willing to prospectively log symptoms and medications during springtime using the CARISTA symptom monitoring platform
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Do not have symptoms of seasonal allergic rhinitis
  • Do not consent to lung function testing and blood sample collection
  • Have unstable asthma (FEV1 less than 70% predicted), recent exacerbation or change in asthma preventive medication use within one month
  • Have severe asthma requiring continuous oral corticosteroids or biological medication
  • Have any medical illness or treatment that may compromise safety or biomarker analysis as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 weeks before spring season

Participants undergo baseline assessments including lung function testing, blood sample collection for biomarkers, and symptom evaluation before the monitoring period.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Over 13 weeks each spring season for up to 3 years

Participants log asthma and allergic rhinitis symptoms and medication use over two consecutive spring seasons using a secure data platform to monitor for seasonal allergic asthma exacerbations.

Ongoing symptom logging throughout each 13-week spring period

Trial Site Locations

Total: 6 locations

1

Albury-Wodonga Health

Albury, New South Wales, Australia, 2640

Actively Recruiting

2

Eastern Health

Box Hill, Victoria, Australia, 3128

Actively Recruiting

3

Monash Health

Clayton, Victoria, Australia, 3162

Actively Recruiting

4

Austin Health

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

5

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

6

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Actively Recruiting

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Research Team

J

Jo A Douglass, MD

R

Rachel Tham, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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