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

NCT04942483 | Completed Results DMC

• 2 other identifiers: 21IC6984300524
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Preschool; Wheeze; Wheezing; Inhaled Corticosteroids; ICS; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Wheeze Attacks

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

  1-year follow-up

Secondary Outcomes (2)

• Days Out of Nursery

  1 year follow-up period

• Parents Days Out of Work

  1 year follow-up period

Other Outcomes (1)

• Acceptability of Biomarker Tests by Parents

  12-months

Study Arms (1)

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).

Diagnostic Test: Blood eosinophil count; Diagnostic Test: Atopic sensitization; Diagnostic Test: FeNO (offline method)

Interventions

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).

Preschool children with a history of wheeze, aged 1 to 5 years old

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.

Preschool children with a history of wheeze, aged 1 to 5 years old

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.

Preschool children with a history of wheeze, aged 1 to 5 years old

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Asthma UK Centre for Applied Research: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Sounds

Interventions

Fractional Exhaled Nitric Oxide Testing

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

FeNO measurements were not obtained in all children due to delayed appreciation that the gas collection bag was faulty. However, a mitigation strategy was utilised to increase the number of children who had FeNO recorded. Children with FeNO measurement at baseline and those with a FeNO measurement in the second, but not baseline testing were combined, giving 68 children with FeNO measurements.

Results Point of Contact

• Title: Professor Andrew Bush
• Organization: Imperial College London

a.bush@imperial.ac.uk

020 7352 8121

Study Officials

• Andrew Bush, MD FHEA FRCP FRCPCH FERS FAPSR

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 28, 2021
• Study Start: November 17, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 24, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-07

Locations

GB (1)