Development of Non-invasive Biomarkers to Direct Individualised Management of Preschool Wheeze

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Observational
SUMMARY

Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations. This has not changed over 20 years, meaning current treatments are not working and a new approach is needed. Currently, all preschool wheezers are treated with inhaled steroids. However, only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. This research group has found that some preschool wheezers may have other causes but there are no specific, non-invasive tests to match the right treatment to each child. The goal of this observational study is to test various bedside tests for this purpose in preschool children with wheeze, to see if they are feasible, accurate and acceptable in this age group. The research team would like to investigate the following aims: Aim 1 - To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation. Aim 2 - To test the acceptability of these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use. Aim 3- A small proof-of -concept study, to test if these simple bedside tests, can be used to determine treatment for each individual child. The panel of simple non-invasive tests that the research team are proposing are: 1. Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds) 2. Finger prick blood test 3. Phlegm test for bacteria 4. Nose and throat swab for bacteria 5. Lung function test called forced oscillation technique (FOT)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 5
Healthy Volunteers: f
View:

⁃ Aim 1, 2 and 3:

• Children aged 1-5 years

• More than 2 hospitalisations for acute wheeze in the last year or

• At least 1 admission requiring high dependency unit or intravenous bronchodilator therapy in the last year.

⁃ Aim 1 only:

⁃ \- children undergoing clinically indicated bronchoscopy, as determined by their existing medical team, as part of their standard management

Locations
Other Locations
United Kingdom
Royal Brompton Hospital
RECRUITING
London
Contact Information
Primary
Cheuk Fung Wong
cheuk-fung.wong@imperial.ac.uk
+4420 7594 9832
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 150
Treatments
Aim 1
To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation.~The aim is correlate the results from the bronchoscopy with the panel of test proposed, and evaluate if these simple bedside tests can pick up the same level of infection or inflammation and obtain the same results, as the bronchoscopy, which is a much more invasive test, but the only method available at present to get this information.
Aim 2
The aim is to test how acceptable these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use.
Aim 3
Small proof-of-concept study. This is for a feasibility trial of using the proposed tests and deciding the treatment of their wheeze, based on the results of the tests. Children with evidence of allergen sensitisation +/- blood eosinophilia (\>0.3x109/L) will be prescribed regular inhaled corticosteroids. Children who are non-atopic (non-atopic is defined as blood eosinophil of \<0.3x109/L + no evidence of allergen sensitisation) with positive bacterial detection in sputum, will be prescribed four weeks of targeted antibiotics. Children who are non-atopic with no bacteria detected in sputum, will be prescribed only be prescribed short acting bronchodilators as required. All medications will be prescribed, as per the British National Formulary for Children, based on age and weight.~The aims of this preliminary study are to understand whether parents will agree to be part of such an interventional trial. This will help the research team when designing a future larger clinical trial.
Related Therapeutic Areas
Sponsors
Collaborators: Action Medical Research, Masonic Charitable Foundation, Royal Brompton & Harefield NHS Foundation Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov