Development of non-invasive biomarkers for preschool wheeze management
Research type
Research Study
Full title
Development of non-invasive biomarkers to direct individualised management of preschool wheeze
IRAS ID
328947
Contact name
Sejal Saglani
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 11 months, 30 days
Research 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, we know that only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. Our 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.
We are aiming to test various bedside tests for this purpose, to see if they are feasible, accurate and acceptable. We will use two tests to identify children who are likely to respond to inhaled steroids: skin tests for allergies and a finger prick blood test. To identify children with bacterial infections in their lungs, where antibiotics will be useful, we will obtain a sample of sputum (phlegm) after a salty mist inhalation (saline nebuliser), and we will test the accuracy of a throat swab that detects bacteria. We will also test how cells called neutrophils work in children without allergies or infection with the same finger prick blood test above. We will use a breathing test called forced oscillation to identify those who may respond to their reliever "blue" inhaler during wheezing attacks.
We will also recruit a small number of children, for a trial in which their treatment will be guided by their test result, to see if parents are willing to take part in such a study, before we design a larger trial. This study will be the first to show that new tests can identify different types of preschool wheezing and can be used to plan treatment based on individual children's needs.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0237
Date of REC Opinion
18 Dec 2023
REC opinion
Further Information Favourable Opinion