CARE-UK(CPMS 59444, IRAS 1009041)

UPDATED - 20/02/2026

STUDY SUMMARY

What is the CARE-UK study all about?

To see if a new inhaler can reduce asthma attacks in children aged 6-11 years.

This new type of inhaler has been shown to work well in older children and adults. However,this treatment option is not currently available to children under 12 years old due to insufficient existing clinical trial data.

This new inhaler contains both a long-lasting reliever and a preventer steroid medicine. This two-in-one inhaler aims to relieve immediate symptoms and also deals with underlying inflammation. It can either be used as needed or every day for both reliever and maintenance treatment.

In this study, we will compare the effectiveness, safety and cost effectiveness of this new inhaler compared to the current treatments.

INCLUSION CRITERIA:

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 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 informed consent

EXCLUSION CRITERIA:

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

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk 

SystmOne:  VACANT

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

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