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Treating severe paediatric asthma; the TREAT trial

  • Research type

    Research Study

  • Full title

    Treating severe paediatric asthma; a randomised controlled trial of mepolizumab and omalizumab (TREAT trial)

  • IRAS ID

    252084

  • Contact name

    Sejal Saglani

  • Contact email

    s.saglani@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Eudract number

    2019-004085-17

  • Clinicaltrials.gov Identifier

    424, ICTU Ref

  • Duration of Study in the UK

    4 years, 6 months, 31 days

  • Research summary

    2-5% of children with asthma have repeated hospital admissions with asthma attacks, school absences and poor quality of life despite being prescribed maximal doses of treatment. A period of treatment monitoring using an electronic device can distinguish patients that have improved control when they take their inhalers properly from those who remain poorly controlled despite taking their treatment; severe therapy resistant asthma (STRA).
    Apart from high dose steroids, which result in severe side effects, there are two medications licensed as add-on treatments in children with STRA. Both are given as regular injections in hospital. Omalizumab can currently only be used in about 60% of children with STRA because prescribing is limited by a blood test called IgE that is related to allergies and also the child’s weight. Of those in whom omalizumab can be tried, only approximately half respond. Mepolizumab was licenced for use in children in 2018. Although safety and the doses have been evaluated, no studies have assessed whether it helps children with STRA.
    In this trial we will firstly check that children with severe asthma are taking their inhalers using electronic monitoring. All children that have poor control despite taking their inhalers (STRA), and those who fail to take their inhalers regularly despite our best efforts to achieve this (these children are at high risk of asthma death), will be eligible. They will have routine clinical tests e.g. breathing tests, blood tests, and bronchoscopy (look inside the lungs with a fibreoptic camera under general anaesthetic) and will be randomly assigned to either receive omalizumab or mepolizumab for one year. We want to know whether mepolizumab is at least as good as omalizumab in reducing asthma attacks in children with severe asthma over the year they are taking the treatment and also what features may predict a good response to either treatment.

  • REC name

    South Central - Berkshire Research Ethics Committee

  • REC reference

    19/SC/0634

  • Date of REC Opinion

    20 Dec 2019

  • REC opinion

    Favourable Opinion