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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Melbourne

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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 . -

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Observational

    Diagnostic test

    Prospective observational study

Treatment groups

530 Participants
are divided into 1 treatment group
Group A: ObservationalOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

1

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
2

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
3

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Melbourne

Lead sponsor

The Alfred

Collaborator

Eastern Health

Collaborator

Austin Hospital, Melbourne Australia

Collaborator

Monash Medical Centre

Collaborator

Queensland University of Technology

Collaborator

Northern Hospital, Australia

Collaborator

Western Hospital, Australia

Collaborator

Melbourne Health

Collaborator