Multi-million pound trial to find the best treatment for severe asthma in children
Three medicines used to treat children who have severe asthma attacks will be compared in a national trial.
Asthma is the most common long-term condition among children and young people.
There are currently three treatment options in the UK for children who have a severe asthma attack.
Findings from this trial will shed light on which treatment is most effective. It will inform clinical guidelines in the future.
The EVITA trial has been awarded over £2.3 million from the National Institute for Health and Care Research (NIHR). Southampton’s Professor Graham Roberts and Dr Katrina Cathie will lead the trial, together with Professor Damian Roland in Leicester.
Childhood asthma
Asthma affects around one in 11 children and young people in the UK.
Many children and young people have severe asthma attacks that do not respond to inhaled reliever medication. This is called severe acute asthma. It can be life-threatening.
Children who experience severe acute asthma will be admitted to hospital and given medication as an injection into a vein.
They will receive one of three treatments: aminophylline, magnesium sulfate or salbutamol. Each one has different side effects.
There is little evidence to show which treatment is most effective. There is also great variation across Europe in how they are used to treat children and young people.
Dr Cathie, a consultant paediatrician and associate director of the NIHR Southampton Clinical Research Facility for paediatrics at University Hospital Southampton, said:
“Paediatricians around the UK and abroad have highlighted this as a crucial area for research to improve how we are able to care for children with acute severe asthma. It is exciting that this study has been funded to finally answer this important question and find out which treatment is best for children.”
Prof Roberts is Professor of Paediatric Allergy and Respiratory Medicine at the University of Southampton. He also co-leads the Respiratory and Allergy theme at the NIHR Southampton Biomedical Research Centre. Prof Roberts added:
“We are working with colleagues from across the UK, as well as parents, young people and the Asthma and Lung UK charity, to develop a trial that will fit into the usual NHS clinical pathways. This means that EVITA will work well for patients, families and our NHS colleagues to provide results that are relevant to today’s busy emergency departments.”
Investigating different treatment options
The trial will take place over three years.
Over 350 children and young people aged two to eighteen will take part. They will be recruited from twenty hospitals across the UK, including University Hospital Southampton and University Hospitals of Leicester.
Children taking part in the trial will be randomly allocated to receive one of the three treatments.
Researchers will monitor which children are getting better the quickest using a validated asthma severity score after two hours. This is based on ratings made by doctors and nurses such as breathing rate.
They will track how long patients stay in hospital and any potential side effects.
Prof Roland is a Paediatric Emergency Medicine Consultant at University Hospitals of Leicester NHS Trust. He said:
“This study will be undertaken in a variety of hospitals in the UK, ensuring that different patient groups are represented.
“We will also be doing a sub study looking at genetic responses to the treatments. This will help us determine if future approaches to treating asthma can be more personalised.”
The research team will also collect data on the costs of treatment. This will help them determine which one delivers the best value for money.
Delivering the trial
The EVITA trial is expected to start in Summer 2025.
It will be coordinated by the Centre for Trials Research at Cardiff University and the Liverpool Clinical Trials Centre. They are both UKCRC registered clinical trials units*.
Dr Joanne Euden is a Research Fellow and EVITA Study lead at Cardiff University Centre for Trials Research. She said:
“We’re delighted to be involved in this important study and to be working closely with Liverpool CTC to coordinate and deliver this vital research to help improve clinical care and outcomes for children and young people with severe acute asthma.”
Professor Carrol Gamble, Director of the Liverpool Clinical Trials Centre, added:
“This builds on our extensive experience in delivering paediatric studies using research without prior consent. It establishes an exciting collaboration to deliver a much-needed study that will bring benefits to children and young people with acute asthma.”
The trial has been funded by the NIHR Health Technology Assessment Programme. It supports high quality research on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests.
Learn more about the EVITA trial on the study website: www.evita.org.uk.
*The Centre for Trials Research at Cardiff University is funded through Welsh Government by Health and Care Research Wales