RecruitingPhase IIInterventional

Prevention of childhood asthma using house dust mite allergen tablets

This research is exploring a new way to prevent asthma in young children. Asthma is very common in the UK and often starts in early childhood. Currently, there’s no way to stop it from developing. This study focuses on house dust mites, which are a major trigger for many children with asthma. We believe that by giving babies a special tablet containing tiny amounts of purified house dust mite allergen, we can help their bodies get used to it and reduce their chances of developing asthma. The study involves babies aged 5 to 12 months who are at higher risk of asthma, for example, if they have close family members with asthma or have early signs of allergies like eczema. Participants will take the tablet once a day for three years. Researchers will regularly check in with families and monitor the children’s health.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Southampton

Enrolment target

434

Start

01 Nov 2025

Estimated completion

01 Oct 2027

Paediatric asthma

What is this study about?

Asthma is a common lung condition in the UK that makes breathing difficult for many people. It often begins when children are very young and can affect them throughout their lives. At the moment, we don't have a way to prevent asthma from developing in the first place, which is why this study is so important. Many children with asthma are affected by things that trigger their allergies, with house dust mites being a very common one.

This study is testing a treatment called Allergen Immunotherapy (AIT). You might have heard of it for people with strong allergies like hay fever, where small amounts of what they're allergic to are given over time to help their body learn to tolerate it. We're applying this idea to asthma prevention. We believe that by giving very specific, purified house dust mite allergens to babies at risk, we can teach their immune systems not to overreact, potentially preventing asthma from starting.

This important research could bring us closer to a future where we can stop asthma before it even begins in some children. It's a Phase II study, which means we're carefully testing the treatment to see if it works as we hope and to understand its effects on young children. Your involvement could help many future generations of children avoid the challenges of asthma.

Key takeaways

A research study to prevent asthma in at-risk babies aged 5-12 months.
Tests a daily house dust mite tablet given for 3 years.
Involves regular check-ups and some clinic visits over several years.
Aims to reduce the risk of developing asthma by helping the body tolerate mites.
Families are closely supported throughout the study.

Who may be eligible?

This study is looking for babies who are between 5 and 12 months old when they officially join. To be considered, your baby must also have a higher chance of developing asthma. This often means having asthma or allergies in your close family (like a parent or sibling) or already showing early signs of allergies themselves, such as having eczema. Each baby’s eligibility will be carefully checked.

Your baby would not be able to join if they have already developed a strong allergy to house dust mites (which would be checked by a skin or blood test), were born very early (before 37 weeks), or have certain other serious health conditions. We also can't include babies who have received certain experimental medicines since birth or if your family plans to move out of the UK within the next four years. The study team also needs to be sure that your family can commit to all the study activities.

It’s important that you, as the parent or guardian, can understand the study information and give your permission for your baby to take part. The study team will discuss all the details with you to make sure your baby is a good fit and that you’re comfortable with everything involved.

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.

Is my baby between 5 and 12 months old?
Does my baby have a close family member (parent or sibling) with asthma or an allergy?
Does my baby already have any signs of allergy, like eczema?
Has my baby ever had a strong allergic reaction to house dust mites?
Does my baby have any other significant health conditions?

Answer every question to see your result.

What does participation involve?

If your baby takes part, they will be randomly assigned to receive either the active house dust mite tablet or a 'dummy' tablet (placebo). Neither you nor the researchers will know which one your baby is receiving. The tablet dissolves quickly and safely in the mouth.

You will need to give your baby this tablet once a day at home for three years. The first time you give the tablet will be at the clinic, where the study team will show you how and watch for 60 minutes afterwards to make sure everything is okay. You'll also get written instructions and can call the study team any time if you have questions.

During the first year, researchers will check in with you and your baby every 6 weeks through phone or video calls. After that, these check-ups will happen every 3 months. If you have any concerns, you can call the team 24 hours a day, and they can arrange an in-person hospital visit if needed. Each year, you’ll also bring your child to the clinic for a visit, which will include answering questions and having some allergy tests. Towards the end of the study, at the last visit, your child will also have a simple breathing test. We will also ask for a small blood sample from your baby at the very beginning and at the very end of the study. This will help us understand if the treatment is working and whether your child has developed early signs of asthma that we call 'allergic wheeze'.

Potential risks and benefits

By taking part, your baby will have access to and be regularly looked after by specialist children's doctors and nurses. If this treatment proves successful, and your baby is in the group that receives the active tablet, it could significantly lower their chance of developing asthma. However, this is still a research study, and we don't know for sure if it will work. The main potential inconvenience for parents is remembering to give the tablet daily for three years and logging this on a special app; alerts will help you with this. There will also be some hospital visits, but an online questionnaire can help avoid unnecessary trips. Taking blood samples involves slight temporary discomfort, but trained staff will use numbing cream to minimise this. You are free to withdraw your child from the study at any time.

Locations (1)

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

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Unverified
United Kingdom

Common questions

What is a 'house dust mite'?

House dust mites are tiny bugs, too small to see, that live in house dust. They are a common cause of allergies and can be a trigger for asthma.

What does a 'Phase II' study mean?

This means it's an early stage of clinical research. We're testing if the treatment is safe and if it seems to work as intended, before it's offered more widely.

Will my baby really get asthma if they don't join?

No one can say for sure if your baby will get asthma. This study is for babies who have a higher chance based on family history or early allergy signs, but it's not a guarantee they will develop it without the study.

What if we move house during the study?

If you move within the UK, you might still be able to continue, but if you plan to move outside the UK within four years, your baby might not be able to join the study.

Will I know if my baby received the real tablet or the dummy tablet?

No, this is a 'blinded' study – neither you nor the researchers will know until the study is over. This helps us get accurate results.

How to find out more

Arzish Haqqee

papatrial@imperial.ac.uk +44 7708297819 Official trial record

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