TAILOR Study
Research type
Research Study
Full title
Biomarkers in preschool children with wheeze to TArget therapy wIth inhaLed cORticosteroids (TAILOR): a feasibility study
IRAS ID
300524
Contact name
Andrew Bush
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 0 days
Research 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. This 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.
Lay summary of study results:
Wheezing is a common condition in preschool-aged children, with frequent hospital visits and days out of nursery. For older children and adults, it has been shown that certain tests could predict how well steroid inhalers might help with their asthma. This study looked at whether similar tests could help predict future wheeze episodes in preschool children and whether these tests would be acceptable to their families.The study recruited 95 children aged 1–5 years who were tested using simple methods: a finger-prick blood test (similar to what diabetics use to measure blood glucose) to measure a type of immune cell called eosinophil, a skin test for allergies, and a breathing test to measure a gas called nitric oxide. Families were followed for a year using monthly questionnaires and children’s medical records.
The results showed that children with high levels of blood eosinophils were more likely to experience wheeze episodes in the year following baseline. The risk was even higher when they additionally had high levels of nitric oxide. The allergy test alone did not predict future wheeze episodes. Prescription of corticosteroid inhalers was associated with fewer wheeze episodes in the first six months, but not thereafter, among children with high blood eosinophil levels. Parents and healthcare professionals deemed these tests acceptable and feasible, respectively.
This study showed that these simple tests could help doctors find children who are more likely to experience wheeze episodes in the year following baseline measurements. More research is needed to see if using these tests could guide treatment decisions and improve outcomes in preschool children with wheeze.
The URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04942483%253Ftab%253Dresults%2FNBTI%2FAW66AQ%2FAQ%2F12031cb1-1e57-421d-a014-d74f026f1c10%2F3%2FhSGqpNpU57&data=05%7C02%7Cqueensquare.rec%40hra.nhs.uk%7C015ed753d25c427deaa408dd2b1e563f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638714131467932598%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=TMeV5nJS0bLk4SYHS2fyJ7O5FtDJ8z53%2FQLbN%2Bn6e%2BQ%3D&reserved=0REC name
London - Queen Square Research Ethics Committee
REC reference
21/PR/1195
Date of REC Opinion
12 Oct 2021
REC opinion
Further Information Favourable Opinion