All studies
RecruitingPhase IIIInterventional

Evaluation of intravenous therapy (i.e. injection into the vein) in asthma

Asthma can cause serious breathing problems, and some children and young people need hospital care for severe attacks. Doctors often give medicines directly into a vein (IV). This study, called EVITA, compares three common IV medicines: aminophylline, magnesium sulphate, and salbutamol. The aim is to see which one works best to help young people recover faster and is most liked by patients and their families. Around 357 children and young people aged 2-18 across many UK hospitals will take part. Participants will be closely monitored, and the study will help doctors improve care for severe asthma attacks in the future.

At a glance

Status
Recruiting
Phase
Phase III
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
357
Start
24 Nov 2025
Estimated completion
15 Sep 2027

What is this study about?

Asthma is a very common lung condition that can make it hard to breathe, leading to shortness of breath and a tight chest. Sometimes, especially with colds or allergies, children and young people can have severe asthma attacks that don't get better with their usual inhaled medicines. When this happens, they might need hospital treatment, which can include medicines given directly into a vein through an injection. Because these severe attacks are a medical emergency, it's really important that doctors know which treatments work best and are most comfortable for young patients.

In the UK, three main medicines are commonly given intravenously (into a vein) for severe asthma attacks: aminophylline, magnesium sulphate, and salbutamol. While doctors know all three can help, they aren't sure which one is the most effective. The EVITA study aims to compare these three medicines to find out which one helps children and young people with severe asthma attacks get better the fastest and is most acceptable to them, their families, and the healthcare staff.

Expert doctors who specialise in children's asthma care will lead this research. They will carefully look at how well each medicine works, how quickly patients recover, and what the experience is like for everyone involved. The results of this study will help doctors across the country choose the best possible care for children and young people experiencing severe asthma attacks in the future.

Key takeaways

  • Compares three common IV medicines for severe asthma attacks in children.
  • Aims to find the most effective and acceptable treatment.
  • Participation involves close monitoring and follow-up.
  • All medicines are routinely used and supervised by trained staff.
  • Helps improve future care for young people with severe asthma.

Who may be eligible?

This study is looking for children and young people aged between 2 and 18 years old who are having a severe asthma attack.

You might be able to take part if you've been diagnosed with asthma before, or if your doctor believes your current breathing problems are due to asthma. You also need to be at a point where your usual inhaled medicines aren't helping enough, and doctors think you need medicine given through a drip (intravenous treatment) straight away.

However, there are reasons you might not be able to join. For example, if you need immediate breathing support through a machine, have certain other long-term lung, kidney, liver, or heart problems, or if you've recently had similar intravenous treatment. You also can't join if you have known allergies to the study medicines or are taking certain other medications that would interfere with the study. Your doctor can discuss all these details with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 2 and 18 years old?
  2. Are you having a severe asthma attack that isn't responding to your usual inhalers?
  3. Do you need urgent medicine given into a vein (an IV drip)?
  4. Do you have any serious underlying health conditions that might prevent you from joining?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the EVITA study, you or your child will be given one of the three commonly used asthma medicines (aminophylline, magnesium sulphate, or salbutamol) through an injection into a vein. Which medicine you get will be decided by chance, like flipping a coin, but you and your care team will know which one it is. The study team will closely watch how quickly you get better using a special asthma score, and they'll keep track of how long you need to stay in the hospital.

Throughout your time in the study, you might be asked to complete some questionnaires and provide a blood sample to check medicine levels. There's also an option to give a saliva (spit) sample, which could help researchers understand if your genes affect how well the treatment works. Some patients, parents, and staff might also be asked for an interview to share their experiences. You'll be followed up for either 30 or 45 days after your hospital stay, depending on whether you choose to do the optional interview.

Potential risks and benefits

Taking part in this study means you'll be monitored very closely by doctors and nurses, which is an extra layer of care. If your care team feels the treatment isn't working or you're having side effects, they can change your medicine at any time. All the medicines used are standard treatments in UK hospitals, and staff are trained to give them safely. While side effects are rare, they are possible with any medicine; however, for these specific treatments, the benefits of getting better from a severe asthma attack are generally much greater than the potential risks. Your participation will provide vital information to help doctors make better decisions for other children and young people with severe asthma attacks in the future. A minor inconvenience is that you'll need to spare some time for follow-up questionnaires. You are free to withdraw from the study at any time without affecting your medical care.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospital Southampton NHS Foundation Trust
    City only
    Southampton, England
  • University Hospitals of Leicester NHS Trust
    City only
    Leicester, England
  • Royal Berkshire NHS Foundation Trust
    City only
    Reading, England
  • University College London Hospitals NHS Foundation Trust
    City only
    London, England
  • Portsmouth Hospitals University NHS Trust
    City only
    Portsmouth, England
  • University Hospitals Bristol and Weston NHS Foundation Trust
    City only
    Bristol, England
  • Leeds Teaching Hospitals NHS Trust
    City only
    Leeds, England
  • Birmingham Women's and Children's NHS Foundation Trust
    City only
    Birmingham, England
  • Royal Devon University Healthcare NHS Foundation Trust
    City only
    Exeter, England
  • University Hospitals of Derby and Burton NHS Foundation Trust
    City only
    Derby, England
  • Alder Hey Children’s Hospital NHS Foundation Trust
    Unverified
    Liverpool, England
  • Somerset NHS Foundation Trust
    Unverified
    Taunton, England

Common questions

What is 'intravenous therapy'?

It means getting medicine directly into a vein, usually through a drip in your arm.

Will I know which treatment I'm receiving?

Yes, both you and your doctors will know which of the three medicines you're being given.

What is the purpose of the blood and saliva samples?

Blood samples check the level of medicine in your body. Saliva samples, which are optional, help researchers see if your genes might affect how well the medicine works.

How long will I be involved in the study?

You'll be followed up for 30 to 45 days after your hospital stay.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

EVITA Trial Team

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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