PREcision Medicine Directed Corticosteroids in Children with PreSchool Wheeze
NCT Number: NCT06580600
Acronym: PRECISE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wheezing
Sponsor: Queen's University, Belfast
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-08

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.

Primary Outcome Measures: Recruitment, Reporting the proportion of eligible patients that are enrolled in the PRECISE Study following screening Reporting all reasons for not screening enrolling any eligible patients., Screening Log completed through study completion, (estimated < 1 year)|Adherance, Reporting the proportion of randomised patients remaining in allocated treatment arm. I.e. how many patients randomised to NOT recieve OCS have received them within 28 days of enrolment., measured at visit 2 and at 28 days post enrolment per patient. Throughout study completion, (estimated < 1 year)|Timeliness, The time (minutes) for i) triage to clinician decision regarding eligibility to enrolment ii) screening until availability of POC test results iii) screening to documented time of randomisation iv) screening to documented time of OCS administration (if applicable), Timeliness measured on CRFs throughout study completion, (estimated < 1 year)|Acceptability, Description of parent/guardian feedback on how acceptable the process of being enrolled and randomised in the study was. This includes a description of perceived barriers to future definitive trial collected from families., Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year))
Secondary Outcome Measures: viral aetiology, To describe viral aetiology of preschool wheeze in included cohort. I.e. the proportions of patients with positive respiratory viral tests for RSV and/or other respiratory virus/ or no virus detected. This includes a description of the CT - values associated with positive respiratory viral test results., Through study completion, (estimated < 1 year)|Concordance of test results, The proportions of patients with discordant respiratory viral tests over consecutive visits., Between enrolment and the second visit. (Throughout study completion, (estimated < 1 year))|Acceptability of tests to formulate plan, To assess parent/guardian acceptability of using a viral POC test in ED to formulate a management plan for pre-school wheeze (using a mixed methods approach)., Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)|Acceptability of tests to be repeated in study, To assess the feasibility of obtaining second nasal/nasopharyngeal (NP) swab and achieving follow up at specified time points, Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)|Airway immune response, Analysis of airway immune responses in preschool wheeze. To describe the immune response associated with preschool wheeeze according to numerous factors, including patient presentation, viral status and OCS use., Analysis to be performed within 1 year of study closure.|blood eosinophil testing in acute setting, To assess the feasibility of obtaining finger prick blood test for peripheral blood eosinophil - count testing:

i) proportion of patients taking up optional finger-prick testing ii) describe the peripheral eosinophil count values in patients undergoing optional testing and associations with viral test results and clinical values., measured at enrolment and visit 2 per patient. Analysis to be completed within 6 months of study closure.