Actively Recruiting
PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
Led by Queen's University, Belfast · Updated on 2025-03-21
120
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
Q
Queen's University, Belfast
Lead Sponsor
A
Asthma UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
Young children frequently attend the emergency department (ED) with wheeze which is usually triggered by a virus infection, such as the common cold. Wheeze can be treated with inhaled medications and sometimes oral steroid medicines are also given to reduce swelling within the lungs. Unfortunately, oral steroids can have side effects. Despite lots of research there is no clear evidence that oral steroids work in young children with a wheeze attack. It is likely that some children get better quicker with oral steroids but deciding who to treat is difficult. This results in differences in care with some children receiving unnecessary oral steroids and others not receiving them when they could benefit. The investigators hypothesise that in a subgroup of children with mild-to-moderate acute wheeze attacks, the viral trigger can predict their response to steroid medications. Previously, respiratory virus testing was too slow to be used to inform treatments in the ED. Now, point-of-care (POC) viral tests can provide results within 30 minutes. There is a research gap regarding the role of these tests in determining steroid responsiveness and outcomes in children presenting with acute wheeze in the pre-school population. In order to address the hypothesis in a future definitive trial, the feasibility of using (POC) viral tests to randomise steroid treatments for children in a clinical study in the ED setting must be ascertained. The PRECISE Study will therefore be a single centre randomised, feasibility study enrolling approximately 60 pre-school aged children to inform a future definitive multi-centre Randomised Controlled Trial.
CONDITIONS
Official Title
PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 24 to 60 months inclusive
- Clinical diagnosis of acute wheeze
- Uncertainty about the benefit of oral corticosteroids as part of standard care
You will not qualify if you...
- Signs or symptoms of severe or life-threatening wheeze
- Wheeze suspected to have a non-respiratory cause
- Clinical evidence of shock or bacterial sepsis
- History of severe or life-threatening asthma or previous intensive care admission due to wheeze
- History of preterm birth before 36 weeks gestation
- Known immunodeficiency or ongoing immunosuppressive treatment
- Contraindication to oral corticosteroids
- Previous participation in the PRECISE Study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Royal Belfast Hospital for Sick Children
Belfast, NI, United Kingdom, BT12 6BA
Actively Recruiting
Research Team
H
Hannah R Norman-Bruce, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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