Biomarkers in preschool children with wheeze to TArget therapy wIth InhaLed cORticosteroids (TAILOR): a Feasibility Study
This study is currently open for recruitment.
This study aims to examine the ability of 3 biomarker tests, which are blood eosinophilic count, atopic sensitisation, and fractional exhaled nitric oxide (FeNO), to predict response to inhaled corticosteroids so that children are given these drugs only when effective and thus avoid their side effects.
Biomarkers in preschool children
Wheezing is common in preschool children and affects their 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 to diagnose 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 the 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.
Are you a parent or guardian of a preschool-aged child who is taking inhaled corticosteroids as a treatment for wheezing? If yes, you may be eligible for this study.
Please complete the following two online forms if you want your child to be involved in the TAILOR study.
Parent/Guardian contact details submission form
This form will be used to contact you and discuss the study further.
Informed consent form
This form gathers your consent for your child to be involved in this study.
PLEASE NOTE: both forms above are hosted through Qualtrics on behalf of Imperial College London.
Parent/Guardian Information Sheet, including Privacy Statement
Download and view the TAILOR project poster - feel free to share with parents or guardians of children aged 1-5 who have been diagnosed with wheezing by their GP or paediatrician.
|Centre Lead: Optimising management of asthma attacks||Asthma UK Centre for Applied Research PhD student|
|Based at: Imperial College London||Based at: Imperial College London|
|Andy's profile||Andreas' PhD profile|
|Reader in Paediatric Respiratory Medicine||Professor of Respiratory Medicine|
|Based at: Imperial College London||Based at: University of Oxford|
|Louise's profile||Ian's profile|
|Centre Director||Doctor in Paediatric Respiratory Medicine|
|Based at: Queen Mary University of London||Based at: Oxford University Hospitals NHS Trust|
|Chris' profile||Sarah-Jane's profile|
From 16 November 2021 to 31 December 2023
Want to know more? Or interested in getting involved?
This project is being carried out from Oxford under the Oxford University Hospitals NHS Foundation Trust
The project is funded by the Asthma UK Centre for Applied Research
The project is sponsored by Imperial College London
The project is approved by the Research Ethics Committee, Reference Number: 21/PR/1195
The project is registered in clinicaltrials.gov, Reference Number: NCT04942483