EVITA

A randomised trial of aminophylline, magnesium sulfate or salbutamol intravenous therapy for acute severe asthma in children and young people.

Asthma is a common lung condition that causes breathing problems. People affected may be short of breath and have a tight chest. Asthma attacks may be triggered by infections like colds or allergies such as dust mites. Many children and young people (CYP) have severe asthma attacks which do not respond to inhaled reliever medication. Hospital treatment may be needed with medication given as an injection into a vein. Three medications are currently used in the UK: aminophylline, magnesium sulfate or salbutamol. Although all three medications are highly effective at treating asthma attacks when given as an injection, doctors are not sure which works the best. Severe asthma attacks in CYP are a common medical emergency so it is important that doctors use the most effective and most acceptable injection treatments for CYP in hospital.

The EVITA trial will compare the three medications (aminophylline, magnesium sulfate or salbutamol) given as an injection and determine which is best at treating severe asthma attacks in CYP. The trial will be led by experts, who work in children’s asthma care, who will compare the medications by looking at how acceptable each treatment is to patients, their families and healthcare professionals, and decide which gives the best value for money to the NHS.

All trial participants will be having a severe asthma attack and not getting better with inhaled medications so deferred consent will be used within the trial. We will request consent for including CYP’s data in the study from parents and then CYP, once their asthma has improved. Everyone taking part in the research study will have an equal chance of receiving one of the three medications. All the participants and their trial teams will know which treatment they have been given within the trial. Overall, we aim to recruit 357 CYP (aged 2-18 years) from UK hospitals.

To see which treatment works best we will look at several results. We will see which children are getting better more quickly by using a validated asthma severity score. This is based on ratings made by doctors and nurses such as heart rate. We will measure how long CYP stay in hospital and compare the side effects of each treatment. Some patients, parents and healthcare staff will be interviewed to understand how they feel about the treatment they received. We will also collect data on the costs of treatment, to allow us to see which treatment delivers the best value for money in the NHS.

We have designed this study with two patient and public involvement (PPI) groups that include parents and CYP: The Asthma UK Centre for Applied Research group (AUKCAR) and The Asthma + Lung UK expert patient panel. The PPI groups will be involved in our trial meetings to help develop the trial documents, make decisions on how the research is run and advise how the research results should be shared with patients and the public.