Children’s anti-inflammatory reliever study, United Kingdom (CARE-UK)

Plain English summary of protocol

Background and study aims
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.

Who can participate?
Children aged ≥6 to <12 years

What does the study involve?
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.

What are the possible benefits and risks of participating?
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.

Where is the study run from?
Imperial College London, UK

When is the study starting and how long is it expected to run for?
June 2023 to February 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR), UK

Who is the main contact?
Louise Fleming, l.fleming2@nhs.net

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Scotland
• Wales

Study participating centres

Results and Publications

Study outputs

Editorial Notes

13/11/2025: The date of final enrolment was changed from 01/08/2025 to 27/02/2026. Study website added.
19/06/2025: Exclusion criteria updated.
16/01/2025: Internal review.
20/06/2024: ISRCTN received notification of combined HRA/MHRA approval for this trial on 20/06/2024
29/01/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).