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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04942483
Other study ID # 21IC6984
Secondary ID 300524
Status Active, not recruiting
Phase
First received
Last updated
Start date November 17, 2021
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 103
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 5 Years
Eligibility Inclusion Criteria: 1. 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 2. Parents/Carers able to understand and familiarize themselves with the study and are willing to provide informed consent Exclusion Criteria: 1. Inability to understand and cooperate with study procedures 2. Significant co-morbidity (respiratory or otherwise), for example cystic fibrosis (excluding atopic disorders such as eczema, allergic rhinitis and food allergy) 3. Withholding or withdrawal of informed consent 4. Severe procedural anxiety (needle phobia) 5. Child is already enrolled in another study involving investigational medicinal product (CTIMP) 6. History of anaphylaxis or near-fatal asthma that resulted in intubation / assisted ventilation.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood eosinophil count
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
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)
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.

Locations

Country Name City State
United Kingdom John Radcliffe Hospital Oxford

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London Asthma UK Centre for Applied Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute attacks of wheeze defined as requiring an unscheduled health care visit Exacerbation of the wheezing condition that will require a visit to a hospital that was not scheduled. This will be determined with monthly electronic questionnaires sent by email to the parents of preschool children with wheeze, as well as by follow-up face-to-face visits in primary care every 3 months. 1 year follow-up period
Secondary Carer days off work Days the parent/carer has taken off work in order to be with their child that has an acute wheezing. This will be determined with monthly electronic questionnaires sent by email to the parents of preschool children with wheeze, as well as by follow-up face-to-face visits in primary care every 3 months. 1 year follow-up period
Secondary Children unable to attend childcare facility Assessing the number of days a child did not attend a childcare facility due to exacerbation of his/her wheezing condition. This will be determined with monthly electronic questionnaires sent by email to the parents of preschool children with wheeze, as well as by follow-up face-to-face visits in primary care every 3 months. 1 year follow-up period
Secondary Use of oral corticosteroids In case a child has been prescribed oral corticosteroids, this has to be declared so that we can assess treatment effectiveness according to the biomarkers tested. This will be determined with monthly electronic questionnaires sent by email to the parents of preschool children with wheeze, as well as by follow-up face-to-face visits in primary care every 3 months. 1 year follow-up period
Secondary Use of inhaled ß-2 agonist (rescue therapy) In case a child has been prescribed ß-2 agonists, this has to be declared so that we can assess treatment effectiveness according to the biomarkers tested. This will be determined with monthly electronic questionnaires sent by email to the parents of preschool children with wheeze, as well as by follow-up face-to-face visits in primary care every 3 months. 1 year follow-up period
Secondary Assessment id respiratory or wheezing condition is under control • Assessment if children's respiratory or wheezing condition is under control by using the TRACKTM score questionnaire (Test for Respiratory and Asthma Control in Kids) 1 year follow-up period
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