PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

NCT ID: NCT06580600

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2025-12-03

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.

Detailed Description

PRECISE will be a feasibility study; conducted as a single-centre, prospective, randomised open-label study. Participants will be screened by the clinical team from attendances to the local Emergency Department (ED). Participants meeting the study inclusion criteria, by age and symptoms, will be entered into a screening log. If the participant is not recruited the reason will be recorded. Participants will be assessed using the inclusion and exclusion criteria (described in other sections). Eligibility will be flagged by a member of the clinical team and then subsequently confirmed by a member of the research team. However, the medical care given to, and medical decisions made on behalf of, participants will be the responsibility of an appropriately qualified treating physician.

The research team member will discuss each eligible participant with their treating physician, to confirm agreement with study enrolment. Parents of eligible children will then be introduced to the research team to provide study information, confirm eligibility, and obtain informed consent. Families will be given time to read the Participant Information Sheets (PIS) and reflect on their discussion with the researcher who will then offer the opportunity to answer further questions. With written informed consent obtained, the participant will be enrolled. This will require the first nasal/nasopharyngeal swab (NPS) to be collected and tested for RSV and other respiratory viral infections. This NPS is for the purposes of the study but results will be made available to the treating clinician and the family. Based on the result of Participants' NPS they will then be randomised to receive oral corticosteroids (OCS) or no OCS through an automated process with a 1:1 ratio. Throughout this process clinicians will continue to perform investigations and administer additional standard of care treatment according to local hospital guidance. Administration of emergency standard of care treatment will not be delayed pending consent discussions or NPS result.

OCS therapy, if given, will be administered as oral dexamethasone according to local standard of care. If the participant vomits within 30 minutes of dexamethasone administration, it may be re-administered at the discretion of the treating clinician. As there is no blinding to the study participants or clinicians regarding the randomisation allocation, the treating clinician may choose to determine the OCS therapy plan at any point after enrolment, irrespective of study randomisation, based on the patient's clinical status.

After the initial ED presentation there are two other time points in the study, i) a review in 2 working days and a phone call at 28 days, post enrolment. UK BTS/SIGN guidance recommends all patients presenting with acute asthma or wheeze should be reviewed following discharge from ED/hospital within two working days. This is not routinely offered locally however, for the purposes of the study, participants will be offered a review with a clinical member of the research team and a repeat nasal swab event will take place. A member of the research team will call parents on day 28 to complete each child's research record.

Additionally, participants may consent to an optional finger prick blood testing at enrolment to elicit their blood eosinophil count using a Point of care (POC) white cell differential device. As with the NPS result, the family and clinicians will be made aware of the result.

Finally parents of participants in the PRECISE study will be invited to take part in semi-structured interviews after the day 28 call for further feasability and acceptability analysis.

Conditions

Wheezing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OCS

To receive OCS (this is standard of care as the children will be recruited if their is clinicial uncertainty over the benefit of OCS, i.e. this is not a CTIMP). The local policy is to prescribe Dexamethasone suspension 300mcg/kg in a single dose.

Group Type: ACTIVE_COMPARATOR

Point of care respiratory virus testing

Intervention Type: DIAGNOSTIC_TEST

Patients to be randomised to receive OCS based on the the result of the RSV results within their respiratory virus test. This test will be performed as a point of care (POC) test in ED.

This intervention will stratify the randomisation in a 1:1 ratio, to receive OCS or not.

NB) Whilst the respiratory pathogen test is not routine care to determine the OCS prescription, it is frequently used within this setting. Additionally both the receipt (or not the receipt) of OCS is within standard care pathway. For the purpose of the trial OCS = Dexamethasone, which is delivered as oral suspension 300mcg/kg as per standard practice within the local Trust.

No OCS

The child will not recieve any cortisteroid medications (this is standard of care as the children will be recruited if their is clinicial uncertainty over the benefit of OCS, i.e. this is not a CTIMP).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Point of care respiratory virus testing

Patients to be randomised to receive OCS based on the the result of the RSV results within their respiratory virus test. This test will be performed as a point of care (POC) test in ED.

This intervention will stratify the randomisation in a 1:1 ratio, to receive OCS or not.

NB) Whilst the respiratory pathogen test is not routine care to determine the OCS prescription, it is frequently used within this setting. Additionally both the receipt (or not the receipt) of OCS is within standard care pathway. For the purpose of the trial OCS = Dexamethasone, which is delivered as oral suspension 300mcg/kg as per standard practice within the local Trust.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

RSV test

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asthma UK

OTHER

Sponsor Role: collaborator

Pediatric Emergency Research in the UK and Ireland (PERUKI)

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Thomas Waterfield

Clinical Lecturer in Paediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen E Groves, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Royal Belfast Hospital for Sick Children

Belfast, NI, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Hannah R Norman-Bruce, MBBS

Role: CONTACT

hnormanbruce01@qub.ac.uk

(+44) 028 9097 1643

Facility Contacts

Hannah Norman - Bruce, MBBS

Role: primary

hnormanbruce01@qub.ac.uk

+447905795231

Other Identifiers

B24/01

Identifier Type: -

Identifier Source: org_study_id