NCT06580600 PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
| NCT ID | NCT06580600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen's University, Belfast |
| Condition | Wheezing |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2025-11-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-11-04 with a primary completion date of 2025-11-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 24-60 months (infants from 24 months +0 days to 60 months + 0 days inclusive) * Clinical diagnosis of acute wheeze * Clinical uncertainty regarding the benefit of OCS as part of patient's standard care Exclusion Criteria: * Signs and symptoms of severe or life-threatening wheeze * Patients presenting with wheeze suspicious for a non - respiratory cause * Clinical evidence of shock or bacterial sepsis * Past history of severe or life-threatening asthma or history of previous PICU admission with acute wheeze * History of preterm birth (before 36+0 weeks gestation) * Known immunodeficiency/ongoing immunosuppressive therapy * Contraindication to oral corticosteroids * Previously enrolled in the PRECISE Study
Contact & Investigator
Helen E Groves, PhD
PRINCIPAL INVESTIGATOR
Queen's University, Belfast
Frequently Asked Questions
Who can join the NCT06580600 clinical trial?
This trial is open to participants of all sexes, aged 24 Months or older, up to 60 Months, studying Wheezing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06580600 currently recruiting?
Yes, NCT06580600 is actively recruiting participants. Contact the research team at hnormanbruce01@qub.ac.uk for enrollment information.
Where is the NCT06580600 trial being conducted?
This trial is being conducted at Belfast, United Kingdom.
Who is sponsoring the NCT06580600 clinical trial?
NCT06580600 is sponsored by Queen's University, Belfast. The principal investigator is Helen E Groves, PhD at Queen's University, Belfast. The trial plans to enroll 120 participants.