WheezingPRECISENCT06580600
PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
A study testing Point of care respiratory virus testing in people with Wheezing, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Wheezing
- What is being tested?
- Point of care respiratory virus testing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2024to 26 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, NI, BT12 6BA
Hannah Norman - Bruce, MBBS, +447905795231, hnormanbruce01@qub.ac.uk
Tom Waterfield, PhD
About this study
Official title: A Single Centre Randomised, Feasibility Study Using Point-of-care (POC) Testing for Respiratory Viruses to Direct Oral Corticosteroids Use in Preschool-aged Children With Acute Wheeze.
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.
Read the 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
- Being tested
- Point of care respiratory virus testing
- Keywords
- pre-school, wheeze, corticosteroid, point-of-care
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care respiratory virus testingDiagnostic test
Also called RSV 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.
| Study group | Role | What they receive |
|---|---|---|
| OCS | Active comparator | 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. Receives: Diagnostic Test: Point of care respiratory virus testing |
| No OCS | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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: 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)
Measured: 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.
Measured: Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year))
Secondary outcomes (6)
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.
Measured: Through study completion, (estimated < 1 year)
Concordance of test results
The proportions of patients with discordant respiratory viral tests over consecutive visits.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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:
- 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: measured at enrolment and visit 2 per patient. Analysis to be completed within 6 months of study closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start4 Nov 2024
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WheezingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomised (1:1) to receive OCS or No OCS (both of which are standard of care)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma UK, Pediatric Emergency Research in the UK and Ireland (PERUKI)
- Responsible party
- Principal investigator, Thomas Waterfield, Queen's University, Belfast
- Investigators
- Helen E Groves, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580600
- Sponsor's protocol ID
- B24/01
- Acronym
- PRECISE
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norman-Bruce H, Mills C, Drummond H, Li K, Mitchell H, McFetridge L, Lyttle M, Roland D, Sinha I, Waterfield T, Groves H. A single-centre randomised, feasibility study using point-of-care (POC) testing for respiratory viruses to direct oral corticosteroids use in preschool-aged children with acute wheeze: a protocol. Pilot Feasibility Stud. 2026 Feb 24;12(1):59. doi: 10.1186/s40814-026-01786-x.
PubMed 41736065
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Randomised, Feasibility Study Using Point-of-care (POC) Testing for Respiratory Viruses to Direct Oral Corticosteroids Use in Preschool-aged Children With Acute Wheeze.
- ClinicalTrials.gov ID
- NCT06580600
- Acronym / sponsor ID
- PRECISE / B24/01
- Conditions
- Wheezing
- Keywords
- pre-school, wheeze, corticosteroid, point-of-care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Asthma UK, Pediatric Emergency Research in the UK and Ireland (PERUKI)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised (1:1) to receive OCS or No OCS (both of which are standard of care)
| Arm | Type | Receives |
|---|---|---|
| OCS | Active comparator | Diagnostic Test: Point of care respiratory virus testingTo 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. |
| No OCS | No intervention | –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). |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care respiratory virus testingAlso: RSV testPatients 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. | Diagnostic test | OCS |
Primary outcome
Recruitment
Time frame: Screening Log completed through study completion, (estimated < 1 year)
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.
Adherance
Time frame: measured at visit 2 and at 28 days post enrolment per patient. Throughout study completion, (estimated < 1 year)
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.
Timeliness
Time frame: Timeliness measured on CRFs throughout study completion, (estimated < 1 year)
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)
Acceptability
Time frame: Collected at 2 and 28 days post enrolment per patient. Data collected through study completion, (estimated < 1 year))
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.
6 secondary outcomes
viral aetiology
Time frame: Through study completion, (estimated < 1 year)
Concordance of test results
Time frame: Between enrolment and the second visit. (Throughout study completion, (estimated < 1 year))
Acceptability of tests to formulate plan
Time frame: Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)
Acceptability of tests to be repeated in study
Time frame: Data collected within one month of enrolment. Throughout study completion, (estimated < 1 year)
Airway immune response
Time frame: Analysis to be performed within 1 year of study closure.
blood eosinophil testing in acute setting
Time frame: measured at enrolment and visit 2 per patient. Analysis to be completed within 6 months of study closure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 41736065Norman-Bruce H, Mills C, Drummond H, Li K, Mitchell H, McFetridge L, Lyttle M, Roland D, Sinha I, Waterfield T, Groves H. A single-centre randomised, feasibility study using point-of-care (POC) testing for respiratory viruses to direct oral corticosteroids use in preschool-aged children with acute wheeze: a protocol. Pilot Feasibility Stud. 2026 Feb 24;12(1):59. doi: 10.1186/s40814-026-01786-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen E Groves, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care respiratory virus testing in people with Wheezing, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah R Norman-Bruce, MBBS ((+44) 028 9097 1643, hnormanbruce01@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Screening Log completed through study completion, (estimated < 1 year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.