Actively Recruiting

Phase Not Applicable
Age: 24Months - 60Months
All Genders
Healthy Volunteers
NCT06580600

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

Age: 24Months - 60Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze | DecenTrialz