Published: 11 September 2020
NIHR has funded a new innovatively designed clinical trial that will aim to find the best treatment for children with mild asthma.
Asthma affects over a million children in the UK, with the main symptoms being a cough and difficulty breathing. This happens because the airways narrow due to swelling and irritation. In the UK, a child with asthma is admitted to hospital every 20 minutes and 20 children die each year from asthma attacks.
Currently, the main treatment is a preventer inhaler, containing steroids, which prevents irritation of the airways. For many years, health professionals have been advising children with asthma to use their preventer inhaler every day to reduce symptoms and prevent attacks. However, new guidelines recommend that taking a preventer inhaler every day might not be required in all children. The new guidelines recommend that in mild asthma, inhalers could be taken only when symptoms occur. These changes are based on results of recent studies in adults, and some teenagers, with asthma.
The results showed no difference in the risk of having an asthma attack if preventer inhalers were only taken when asthma symptoms occurred.
In order to learn how best to treat children with mild asthma, a team led by researchers from the University of Liverpool and from Alder Hey Children's NHS Foundation Trust have launched the £1.5m clinical trial to find out if taking a preventer inhaler only when a child has symptoms is as effective as taking it every day.
The study, Assessing SYmptom-driven versus Maintenance Preventer Therapy for the Outpatient Management of AsThma In Children (ASYMPTOMATIC), will involve around 250 GP practices across the UK. If their parents agree, children aged 6-16 will be randomly assigned to either use their preventer inhaler daily or only when they have asthma symptoms. Care for the children will then be as it would in routine practice, and the data required extracted from electronic health records, thus minimising the burden for participants.
Co-chief investigator Associate Clinical Professor Ian Sinha, at Alder Hey,said: “The trial will answer one of the most pressing and important questions about the fundamentals of managing childhood asthma. This is a condition which affects many millions of children, worldwide. We need a study to know the best way to control their inflammation – on the one hand we don’t want to put children at risk of asthma attacks, but on the other hand we don’t want to expose them to side effects of medications if we don’t need to. Given the differences between paediatric and adults asthma, it is right that we conduct studies in children”.
Co-Chief investigator Paula Williamson, Professor of Medical Statistics at the University of Liverpool, said: “This funding will enable us to conduct this innovatively designed study which will use routinely collected data, in collaboration with Clinical Practice Research Datalink and the Liverpool Clinical Trials Centre. This type of study directly responds to the top priority identified by patients and the public for clinical research, namely, to answer how can randomised trials become part of routine care and best utilise current clinical care pathways? *“
Other organisations involved in the study include; Queen Mary University of London; Bangor University; Asthma UK Centre for Applied Research, The University of Edinburgh; The National Heart and Lung Instituteand Imperial College London.
The project has been funded by the NIHR Health Technology Assessment (HTA) Programme. See the project page for more details.