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

Completed

Conditions: Wheezing

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

Registration Number: NCT04942483

Lead Sponsor: Imperial College London

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 118

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preschool children with a history of wheeze, aged 1 to 5 years old	Atopic sensitization	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).
Preschool children with a history of wheeze, aged 1 to 5 years old	Blood eosinophil count	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).
Preschool children with a history of wheeze, aged 1 to 5 years old	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).

Primary Outcome Measures

Name	Time	Method
Wheeze Attacks	1-year follow-up	Defined as requiring an unscheduled healthcare visit to the ED or GP.

Secondary Outcome Measures

Name	Time	Method
Days Out of Nursery	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.
Parents Days Out of Work	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.