An interventional study of Point of care respiratory virus testing in Wheezing, sponsored by Queen's University, Belfast. Recruiting at 1 site in United Kingdom. Open to participants aged 24 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Other
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.
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.
189 studies on the registry are indexed under Respiratory Sounds; 41 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 98 interventional studies indexed under Respiratory Sounds.
Browse Respiratory Sounds studies →Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Point of care respiratory virus testing
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).
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.
Also known as: RSV test
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year))
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.
Time frame: Through study completion, (estimated < 1 year)
Concordance of test results
The proportions of patients with discordant respiratory viral tests over consecutive visits.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: measured at enrolment and visit 2 per patient. Analysis to be completed within 6 months of study closure.
Plan to share: No
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