CARE-UK study
Key information
Chief Investigator: Dr Louise Fleming
Sponsor: Imperial College London
ICTU Therapeutic area: Child Health
Email: care-study@imperial.ac.uk
Study website: Not yet live.
Trial registration: N/A
Status: Set-up
The CARE-UK trial is 52-week multi-centre (across the UK), parallel group, open label, pragmatic, two-arm randomised controlled paediatric asthma trial.
This study is investigating whether a new type of asthma reliever inhaler reduces asthma attacks in children aged 6 to 11 years. The standard reliever inhaler (short acting beta agonists - SABA) only opens up the breathing tubes (airways). The new inhaler ICS (inhaled corticosteroids)-Formoterol is called a combination inhaler. As well as opening the airways it also contains a steroid to reduce airway swelling. This means that as well as relieving symptoms the underlying airway inflammation is also being treated. This inhaler, called a
combination inhaler can be used instead of the usual reliever medication on its own for people with infrequent asthma symptoms. For those with more troublesome symptoms it can be used as both a regular preventer and, when symptoms occur, also as a reliever.
One thousand three hundred and fifty two Children are randomly allocated to one of two groups:
1. Usual care, no change in treatment
2. The new approach, which will use the new combination inhaler either on its own as a reliever when symptoms occur or for both maintenance and reliever treatment