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Completed

NCT Number: NCT04942483

Using Tests in Preschool Children With Wheeze to Determine the Need for Inhaled Corticosteroid Therapy.

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.

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Blood eosinophil count

Diagnostic 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 sensitization

Diagnostic 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.

Primary outcomes

  1. Wheeze Attacks

    Time frame: 1-year follow-up

    Defined as requiring an unscheduled healthcare visit to the ED or GP.

Secondary outcomes

  1. Days Out of Nursery

    Time frame: 1 year follow-up period

    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.

  2. Parents Days Out of Work

    Time frame: 1 year follow-up period

    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.

Other outcomes

  1. Acceptability of Biomarker Tests by Parents

    Time frame: 12-months

    The acceptability of the three biomarker tests by parents to be used in clinical practice was assessed through focus group discussions.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Asthma UK Centre for Applied Research

Registry information

Official study title

Biomarkers in Preschool Children With Wheeze to TArget Therapy wIth inhaLed cORticosteroids (TAILOR): a Feasibility Study".

Acronym: TAILOR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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