WheezingTAILORNCT04942483
Using Tests in Preschool Children With Wheeze to Determine the Need for Inhaled Corticosteroid Therapy.
An observational study of Wheezing, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Wheezing is common in preschool children and affects quality of life. Although asthma treatments such as inhaled steroids (ICS), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Wheezing
- What is being tested?
- Blood eosinophil count, Atopic sensitization and FeNO (offline method)
- How many people
- 118 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged one to five years old presenting either to primary care with wheezing episodes or to emergency departments or urgent care centres with an acute attack of wheeze or children identified from primary care records and have been diagnosed with wheezing by their GP or paediatrician.
Who may be able to join
- Patients aged one to five years old presenting to primary care or emergency department or urgent care centre or identified from primary care records and have been diagnosed with wheezing by their GP or paediatrician who has decided to prescribe any bronchodilator, ICS or montelukast on clinical grounds
- Parents/Carers able to understand and familiarize themselves with the study and are willing to provide informed consent
Who cannot join
- Inability to understand and cooperate with study procedures
- Significant co-morbidity (respiratory or otherwise), for example cystic fibrosis (excluding atopic disorders such as eczema, allergic rhinitis and food allergy)
- Withholding or withdrawal of informed consent
- Severe procedural anxiety (needle phobia)
- Child is already enrolled in another study involving investigational medicinal product (CTIMP)
- History of anaphylaxis or near-fatal asthma that resulted in intubation / assisted ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers in Preschool Children With Wheeze to TArget Therapy wIth inhaLed cORticosteroids (TAILOR): a Feasibility Study".
Wheezing is common in preschool children and affects quality of life. Although asthma treatments such as inhaled steroids (ICS), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. That is because only some preschool children have the type of inflammation (known as Type 2 inflammation) that responds to ICS, thus many children are being unnecessarily exposed to side effects. It is difficult diagnosing Type 2 inflammation through history and examination, thus other indicators are needed to ensure ICS are only given to children who will benefit. These indicators are commonly known as biomarkers, and we are trying to find out if they are useful. We want to measure three biomarkers, without changing children's treatment. The first is blood eosinophils. which can be measured using a finger prick sample (like the blood drop used for measuring sugar levels in diabetic children). The second is to determine if allergic sensitization is present to allergens that are breathed in; these will be house dust mite, grass pollen, tree pollen, cat and dog hair. The final biomarker is a molecule that is produced in the airways of preschool children with Type 2 inflammation, called nitric oxide (NO). This is easily obtained, by having children breathe through a mask and collecting their breath in a bag, measuring NO later on. The children will be followed up with monthly electronic questionnaires and 3-monthly visits (virtual or face-to-face) for a year to evaluate whether these markers individually or in combination relate to subsequent wheezing outcomes, and how acceptable the measurements are to families using a questionnaire and focus group approach. The results will form the basis of the design of a national trial of biomarker-driven therapy in such children.
- Conditions
- Wheezing
- Being tested
- Blood eosinophil count, Atopic sensitization, FeNO (offline method)
- Keywords
- Preschool, Wheeze, Wheezing, Inhaled Corticosteroids, ICS, Biomarkers
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood eosinophil countDiagnostic test
Peripheral blood eosinophil count will be measured from a finger prick blood sample, using the Haemocue machine, allowing a result in approximately 2 minutes. The test will allow to assess the presence or not of eosinophilia and if it can predict future wheezing exacerbations and response to inhaled corticosteroids (ICS).
Atopic sensitizationDiagnostic test
Skin prick tests will be performed to: (a) house dust mite, (b) grass pollen, (c) tree pollen, (d) cat hair, (e) dog hair, as well as normal saline and histamine which will act as negative and positive controls respectively. In addition, skin prick tests will allow the assessment of which aeroallergen is the most useful predictor of outcomes in preschool children.
FeNO (offline method)Diagnostic test
The child will breathe normally into a sample bag that will be collected for later analysis of FeNO levels. The test will be performed twice.
| Study group | Role | What they receive |
|---|---|---|
| Preschool children with a history of wheeze, aged 1 to 5 years old | This is a pragmatic, observational study involving preschool children with wheeze aged one to five years old. All treatment and routine monitoring decisions will be at the discretion of their treating general practitioner (GP) or paediatrician (as per usual clinical practice), blinded to the study measurements.
The following three biomarker tests will be performed a) atopic sensitisation, b) blood eosinophil count and c) FeNO (off-line method). Receives: Diagnostic Test: Blood eosinophil count; Diagnostic Test: Atopic sensitization; Diagnostic Test: FeNO (offline method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheeze Attacks
Defined as requiring an unscheduled healthcare visit to the ED or GP.
Measured: 1-year follow-up
Secondary outcomes (2)
Days Out of Nursery
Children unable to attend childcare facility due to a wheeze attack. There were no arms in this study, only a single group followed in an identical manner.
Measured: 1 year follow-up period
Parents Days Out of Work
Days out of work parents needed to take because of their child's wheeze attack. There were no arms in this study, only a single group followed in an identical manner.
Measured: 1 year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start17 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WheezingStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma UK Centre for Applied Research
- Responsible party
- Sponsor
- Investigators
- Andrew Bush, MD FHEA FRCP FRCPCH FERS FAPSR, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942483
- Sponsor's protocol ID
- 21IC6984
- Other IDs
- 300524
- Acronym
- TAILOR
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2021
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Preschool Children With Wheeze to TArget Therapy wIth inhaLed cORticosteroids (TAILOR): a Feasibility Study".
- ClinicalTrials.gov ID
- NCT04942483
- Acronym / sponsor ID
- TAILOR / 21IC6984
- Conditions
- Wheezing
- Keywords
- Preschool, Wheeze, Wheezing, Inhaled Corticosteroids, ICS, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Asthma UK Centre for Applied Research
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Wheezing is common in preschool children and affects quality of life. Although asthma treatments such as inhaled steroids (ICS), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. That is because only some preschool children have the type of inflammation (known as Type 2 inflammation) that responds to ICS, thus many children are being unnecessarily exposed to side effects. It is difficult diagnosing Type 2 inflammation through history and examination, thus other indicators are needed to ensure ICS are only given to children who will benefit. These indicators are commonly known as biomarkers, and we are trying to find out if they are useful. We want to measure three biomarkers, without changing children's treatment. The first is blood eosinophils. which can be measured using a finger prick sample (like the blood drop used for measuring sugar levels in diabetic children). The second is to determine if allergic sensitization is present to allergens that are breathed in; these will be house dust mite, grass pollen, tree pollen, cat and dog hair. The final biomarker is a molecule that is produced in the airways of preschool children with Type 2 inflammation, called nitric oxide (NO). This is easily obtained, by having children breathe through a mask and collecting their breath in a bag, measuring NO later on. The children will be followed up with monthly electronic questionnaires and 3-monthly visits (virtual or face-to-face) for a year to evaluate whether these markers individually or in combination relate to subsequent wheezing outcomes, and how acceptable the measurements are to families using a questionnaire and focus group approach. The results will form the basis of the design of a national trial of biomarker-driven therapy in such children.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preschool children with a history of wheeze, aged 1 to 5 years old | – | Diagnostic Test: Blood eosinophil count, Diagnostic Test: Atopic sensitization, Diagnostic Test: FeNO (offline method)This is a pragmatic, observational study involving preschool children with wheeze aged one to five years old. All treatment and routine monitoring decisions will be at the discretion of their treating general practitioner (GP) or paediatrician (as per usual clinical practice), blinded to the study measurements. The following three biomarker tests will be performed a) atopic sensitisation, b) blood eosinophil count and c) FeNO (off-line method). |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged one to five years old presenting either to primary care with wheezing episodes or to emergency departments or urgent care centres with an acute attack of wheeze or children identified from primary care records and have been diagnosed with wheezing by their GP or paediatrician.
Key inclusion criteria (2 listed)
- Patients aged one to five years old presenting to primary care or emergency department or urgent care centre or identified from primary care records and have been diagnosed with wheezing by their GP or paediatrician who has decided to prescribe any bronchodilator, ICS or montelukast on clinical grounds
- Parents/Carers able to understand and familiarize themselves with the study and are willing to provide informed consent
Key exclusion criteria (6 listed)
- Inability to understand and cooperate with study procedures
- Significant co-morbidity (respiratory or otherwise), for example cystic fibrosis (excluding atopic disorders such as eczema, allergic rhinitis and food allergy)
- Withholding or withdrawal of informed consent
- Severe procedural anxiety (needle phobia)
- Child is already enrolled in another study involving investigational medicinal product (CTIMP)
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 |
|---|---|---|
| Blood eosinophil countPeripheral blood eosinophil count will be measured from a finger prick blood sample, using the Haemocue machine, allowing a result in approximately 2 minutes. The test will allow to assess the presence or not of eosinophilia and if it can predict future wheezing exacerbations and response to inhaled corticosteroids (ICS). | Diagnostic test | Preschool children with a history of wheeze, aged 1 to 5 years old |
| Atopic sensitizationSkin prick tests will be performed to: (a) house dust mite, (b) grass pollen, (c) tree pollen, (d) cat hair, (e) dog hair, as well as normal saline and histamine which will act as negative and positive controls respectively. In addition, skin prick tests will allow the assessment of which aeroallergen is the most useful predictor of outcomes in preschool children. | Diagnostic test | Preschool children with a history of wheeze, aged 1 to 5 years old |
| FeNO (offline method)The child will breathe normally into a sample bag that will be collected for later analysis of FeNO levels. The test will be performed twice. | Diagnostic test | Preschool children with a history of wheeze, aged 1 to 5 years old |
Primary outcome
Wheeze Attacks
Time frame: 1-year follow-up
Defined as requiring an unscheduled healthcare visit to the ED or GP.
2 secondary outcomes
Days Out of Nursery
Time frame: 1 year follow-up period
Parents Days Out of Work
Time frame: 1 year follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Lower Respiratory Tract Infection (LRTI), Recurrent Wheezing
RecruitingPhase 3
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Wheezing, LRTI
RecruitingObservational study
N-WATCH: Nottingham Wheeze Assessment in Tidal Children
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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. This study is not recruiting at the moment.
Andrew Bush, MD FHEA FRCP FRCPCH FERS FAPSR principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing, run by Imperial College London 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheeze Attacks (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.