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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Keith Boland
k.boland@imperial.ac.uk


Dr Louise Fleming
L.Fleming@rbht.nhs.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Children’s anti-inflammatory reliever study, United Kingdom (CARE-UK)
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Children’s anti-inflammatory reliever study, United Kingdom (CARE-UK)

Recruiting

Open to: All Genders

Age: Child

London London Leicester London Cambridge Bristol Southampton Glasgow Liverpool Leeds London London Aberdeen Nottingham Norwich Oxford Birmingham Stoke-on-Trent Brighton Manchester Newcastle upon Tyne Sheffield Cardiff

Medical Conditions

Paediatric asthma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study aims to see if a new type of asthma reliever inhaler reduces asthma attacks in children. Children who have asthma attacks are treated with reliever medications (blue inhalers), which act quickly to briefly open the airways when they become narrow but their effect soon wears off. These blue inhalers don't treat the underlying problem, airway inflammation (swelling). Asthma attacks can be prevented with an inhaled steroid treatment (usually brown/purple inhalers which prevents the underlying airway swelling), a maintenance treatment. This new type of combination reliever inhaler contains a fast-acting steroid working by helping to dampen inflammation and is usually taken regularly/every day. In adults and teenagers, this inhaler has been shown to work well by relieving symptoms and treating the underlying airway inflammation resulting in fewer asthma attacks. This combination inhaler can be used instead of the usual reliever medication on its own for people with infrequent asthma symptoms or as both a regular preventer and a reliever for those with more troublesome symptoms.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Dec 2024 31 Aug 2026

Children will be randomly allocated to one of 2 groups:
1. Usual care, no change in treatment
2. The new approach, using the combination inhaler on its own as a reliever when symptoms occur or for both maintenance and reliever treatment
This study will identify children through GP records, and attendance at hospital asthma clinics or they may self-refer through social media adverts. Once they have agreed to take part in the study, the study team will ask that they attend 4 visits in total, some face-to-face, some over the telephone, and some in person at their local study site. The study will see which group has the most asthma attacks requiring a course of steroid tablets. The results of the trial will change National asthma guidelines and findings may be shared by Asthma and Lung UK on their platforms.


Children aged ≥6 to <12 years

You can take part if:


Current inclusion criteria as of 10/02/2026:
1. Clinician diagnosis of asthma
2. Children aged ≥6 to <12 years
3. Washout period of 6 months post previous IMP studies
4. Prescribed asthma medication, (within license) in past 6 months (SABA (salbutamol) with or without ICS or ICS+LABA)
5. Parent or carer able to understand the study requirements and willing to provide info


You may not be able to take part if:


Current exclusion criteria as of 10/02/2026:1. Other chronic airways disease including but not limited to bronchiectasis, cystic fibrosis, sickle cell disease 2. Children prescribed non-salbutamol SABA (e.g. terbutaline) as their reliever 3. Already using ICS-formoterol as a reliever 4. Children on step 5, very high dose treatment (e.g. high dose ICS/LABA, prescription of biological therapy such as omalizumab) 5. Any known or suspected contraindications to the medications prescribed in the study or their respective excipients: 5.1. Apaflurane (HFA 227) 5.2. Povidone 5.3. Macrogol

Previous exclusion criteria:1. Other chronic airway diseases including but not limited to bronchiectasis, cystic fibrosis, sickle cell disease 2. Already using ICS-formoterol as a reliever3. Children on step 5, very high dose treatment (e.g. high dose ICS/LABA, prescription of biological therapy such as omalizumab)

Added 19/06/2025:4. Any known or suspected contraindications to the medications


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal London Hospital
    Whitechapel
    London
    E1 1BB
  • Great Ormond Street Hospital for Children
    Great Ormond Street
    London
    WC1N 3JH
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • Kings College Hospital
    Mapother House De Crespigny Park Denmark Hill
    London
    SE5 8AB
  • Addenbrookes Hospital
    Hills Road
    Cambridge
    CB2 0QQ
  • Bristol Royal Hospital for Children
    Paul O'Gorman Building Upper Maudlin Street St Michael's Hill
    Bristol
    BS2 8BJ
  • Southampton Children's Hospital
    Southampton General Hospital Tremona Road
    Southampton
    SO16 6YD
  • Royal Hospital for Sick Children (Glasgow)
    1345 Govan Road
    Glasgow
    G51 4TF
  • Alder Hey Children's Hospital
    E Prescot Rd
    Liverpool
    L14 5AB
  • Leeds Children's Hospital
    Leeds General Infirmary Clarendon Wing
    Leeds
    LS1 3EX
  • St Georges University Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Evelina London Children's Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • Westburn Medical Group
    Foresterhill Health Centre Aberdeen Royal Infirmary Foresterhill Road
    Aberdeen
    AB25 2XE
  • Nottingham Children's Hospital
    Queen's Medical Centre, Derby Rd
    Nottingham
    NG7 2UH
  • Jenny Lind Children's Hospital
    Norfolk and Norwich University Hospital, Colney Lane
    Norwich
    NR4 7UY
  • Oxford Children's Hospital
    John Radcliffe Hospital, Headington
    Oxford
    OX3 0AG
  • Birmingham Children's Hospital
    Steelhouse Ln, Queensway
    Birmingham
    B4 6NH
  • Staffordshire Children's Hospital at Royal Stoke
    Royal Stoke University Hospital, Newcastle Road
    Stoke-on-Trent
    ST4 6QG
  • Royal Alexandra Children's Hospital
    North Dr, Brighton and Hove
    Brighton
    BN2 5BE
  • Royal Manchester Children's Hospital
    Manchester Royal Infirmary, Oxford Rd
    Manchester
    M13 9WL
  • Great North Children's Hospital
    Victoria Wing, Royal Victoria Infirmary
    Newcastle upon Tyne
    NE1 4LP
  • Sheffield Children's Hospital
    The University of Sheffield, Clarkson St, Broomhall
    Sheffield
    S10 2TH
  • Noah's Ark Children's Hospital for Wales
    University Hospital of Wales, Heath Park Way
    Cardiff
    CF14 4XW

Children in both groups of the study will have access to the study team, who will make sure parents and children know how to take their inhalers, have an up-to-date Personal Asthma Action Plan and know when to seek help. It is hoped that those in the intervention group will find it easier to have just one inhaler to use.
If the child is on the intervention arm, using the combination inhaler, there may be a period where the child will need to adjust to the new inhaler. The schools will have to get used to the revised Asthma Action Plan as the number of puffs of the new reliever inhaler will be different to the number of puffs of the blue reliever inhaler. Detailed directions will be sent to the schools about students who are taking part in the trial and their new Personalised Asthma Action Plan. Parents will also be encouraged to review the new Personalised Asthma Action Plan closely with the children's teachers to ensure everyone in contact with the child is aware of the change of plans.
The new combination inhaler contains steroids which can affect growth. The study will measure height at the onset of the study and the end. Some children will be given an electronic monitoring device for their inhalers so the study team can keep track of how much medicine they have taken. For all children, prescription records will be checked so that inhaled steroid doses and courses of oral steroids can be compared in each group. The risk burden is fairly low for these patients and the long-term benefits of controlled asthma, and hence reduction in asthma attacks needing a course of steroids, outweigh the potential side effects.

Dr Louise Fleming
L.Fleming@rbht.nhs.uk


Dr Keith Boland
k.boland@imperial.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Imperial College London and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN65432808

Or CPMS: 59444

Last updated 10 February 2026

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