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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Observational
Diagnostic testProspective observational study
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Other outcomes
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.
Number of Participants with Hospital presentations for asthma
Hospital emergency attendance for worsening of acute asthma
Number of Participants with Emergency attendance for asthma care
Emergency attendance to a clinical facility for acute asthma care
Sponsors and contacts
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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