AuthorisedTherapeutic use (Phase IV)Interventional

BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)

This study, called BIO-GRAIL, is for people with severe asthma. It's looking at different modern biological medicines like Nucala, Cinqaero, Dupixent, Fasenra, and Tezspire. The main goal is to see if these treatments can help keep your asthma stable and under control for about a year, even if your doctor gradually increases the time between your doses. "Asthma control" means having fewer than two flare-ups (exacerbations) in a year compared to before, and a low score on an asthma questionnaire. Researchers also want to check how these medicines affect breathing, allergy markers in the blood, and your overall quality of life. It's about finding the best way to manage severe asthma and make your life better.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC Stichting

Enrolment target

142

Start

05 Jun 2026

Severe Asthma

What is this study about?

This study, called BIO-GRAIL, is for people in the UK who have severe asthma. Severe asthma means your asthma is hard to control, even with strong regular medicines. The study is looking at several newer types of medicines, called biological treatments, including Nucala, Cinqaero, Dupixent, Fasenra, and Tezspire. These aren't like your usual inhalers; they target specific parts of your immune system that cause asthma symptoms.

The main aim of this study is to see if, over about one year, these biological medicines can help you keep your asthma well under control, even if your doctor carefully stretches out the time between your doses. "Well under control" means you shouldn't have many more asthma flare-ups than you had before starting the study, and your asthma symptoms should be much better according to a special questionnaire. A flare-up means your symptoms get much worse for more than two days, needing extra treatment. The study is trying to understand if we can use these powerful medicines more efficiently while still keeping your asthma stable.

Researchers will also be looking at many other things to understand how these treatments work. This includes checking things like how often you have flare-ups, certain markers in your blood and breath that relate to asthma and allergies, how well your lungs are working (like how much air you can breathe out), and how your asthma affects your daily life and sinuses. They will also look at whether you're using your inhalers correctly and how well you take your medicines. All this information will help doctors understand the best way to use these treatments for people with severe asthma.

Key takeaways

Study for adults with severe asthma already on biological treatment.
Investigates if dose intervals can be safely lengthened while keeping asthma controlled.
Aims to improve long-term management of severe asthma.
Involves regular health checks and tests over about one year.
Uses existing, approved biological medicines like Nucala and Dupixent.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to everyone, regardless of whether you are male or female.

In general, the study is looking for people who have severe asthma that is currently being treated with one of the biological medicines mentioned (Nucala, Cinqaero, Dupixent, Fasenra, or Tezspire). You would likely need to have been on one of these treatments for some time and your asthma should be reasonably stable before you can join.

Your doctor would need to check all your medical details to make sure this study is right for you. They will look at your asthma history, any other health conditions you have, and the specific medicines you are taking to ensure your safety and that you meet all the detailed requirements for the study.

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.

Are you 18 years old or older?
Do you have severe asthma?
Are you currently receiving a biological treatment for your asthma (like Nucala, Cinqaero, Dupixent, Fasenra, or Tezspire)?
Has your doctor told you your asthma is reasonably stable?
Are you able to attend regular appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you join the study, you would continue to receive your biological asthma medicine, but your doctor might gradually start to increase the time between your doses. This would be done very carefully and only if your asthma remains stable. You would have regular visits to your clinic or hospital over about one year. During these visits, doctors and nurses will check how your asthma is doing. This will involve answering questions about your symptoms, taking lung function tests (like blowing into a machine), and having blood and breath tests to check certain asthma markers. They might also check your inhaler technique and how well you're taking your medicines. If you have an asthma flare-up, they might test you for common respiratory viruses. The total duration of your active participation in the study is about one year, with careful monitoring throughout.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as very close monitoring of your asthma by experts and access to the latest biological treatments. The main aim is to find ways to manage severe asthma more effectively, potentially improving your quality of life. However, like any medical treatment or study, there can be potential risks, such as side effects from the medicines, or your asthma not remaining as well controlled if the dose interval is changed. All procedures carry a small risk, and there might be some inconvenience from clinic visits. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What is severe asthma?

Severe asthma is when your asthma is difficult to control, even with high doses of standard asthma medicines, causing frequent symptoms or flare-ups.

What are biological treatments?

Biological treatments are newer medicines for severe asthma that target specific parts of your body's immune system to reduce inflammation and asthma symptoms.

What does 'interval prolongation' mean?

It means your doctor might gradually increase the time between your doses of biological medicine, to see if your asthma stays controlled with less frequent treatment.

Will I get a new medicine in this study?

No, this study is looking at biological medicines that are already available, not new ones. You would continue with one of these approved treatments.

How long will I be in the study?

Your active participation in the study, including regular check-ups, will last for about one year.