Active not recruitingOBSERVATIONAL

Cohort Analysis of Clinical and Biological Severe Childhood Asthma

This study aims to understand what makes some children's asthma really severe. Researchers want to find out why this happens, how it affects their health, and how it changes from childhood into adulthood. They'll be looking at children aged 3 to 18, both those with severe asthma and those with milder forms, to compare their experiences. Taking part means sharing information about health, lung function, and allergies. Some children might have more detailed checks. The study hopes to shed light on severe asthma so doctors can find better ways to help children manage it and live healthier lives.

At a glance

Status

Active not recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

362

Start

12 Nov 2013

Estimated completion

01 Nov 2032

Severe Asthma

What is this study about?

Imagine asthma as a spectrum, where some children have it very mildly, and others struggle a lot more. This study focuses on those children whose asthma is really severe, affecting about 5 out of every 100 children with asthma. For these children, severe asthma can lead to more hospital visits, missing school, and generally impacts their daily lives quite a bit.

Even though we've learned a lot about asthma, there are still many questions about why some children's asthma is so bad, what makes it worse, and how it affects them as they grow up. This study wants to answer these questions by looking closely at groups of children with and without severe asthma. By understanding the different types of severe asthma and the factors involved, researchers hope to improve how children are treated and cared for.

They're aiming to find out what makes asthma severe, what happens to children with severe asthma over time, and what factors might link childhood asthma to asthma in adulthood. This could help doctors predict who might develop severe asthma and develop better treatments in the future.

Key takeaways

The study investigates severe asthma in children.
It aims to identify causes, outcomes, and links to adult asthma.
Children with both severe and non-severe asthma can participate.
Participation involves health checks, lung function tests, and blood samples.
The study observes children over several years.
Findings could improve understanding and treatment of asthma.

Who may be eligible?

This study is looking for children aged 3 to 12 years old. They are interested in two main groups: children with severe asthma and children with non-severe asthma.

For children with **severe asthma**, this means their asthma is still causing problems even after they've been using strong asthma medicines regularly. This could include having symptoms most days, needing to use their reliever inhaler often, or having had several asthma attacks or hospital stays in the last year. If a child is already taking a specific medicine called Xolair®, they can still be included if their asthma was severe before they started that treatment.

For children with **non-severe asthma**, this means their asthma is generally well-controlled, either without regular medicine or with a low dose of inhaled medicine. They shouldn't have had any very bad asthma attacks or hospital stays in the last year. Parents will need to give their permission for their child to join the study. Children will not be able to join if they have certain other lung conditions or if they or their parents don't want to take part.

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 child between 3 and 12 years old?
Does my child have severe asthma (even with strong medicines) OR well-controlled, milder asthma?
Has my child NOT had certain other lung conditions?
Am I, as a parent, willing to give permission for my child to take part?

Answer every question to see your result.

What does participation involve?

If your child joins the study, the researchers will collect information at the start. This includes details about their health, environment, how well their lungs are working, and allergy test results (like skin prick tests and blood tests for allergies). They will also take some blood samples, which will be stored for future research. For a small number of children, a more detailed check-up might be done, which could involve looking inside their airways with a tiny camera.

Children with severe asthma will have follow-up visits every 6 months. These visits will check their health and how their lungs are working. Their allergy status will be re-checked when they are 6-7, 12, and 18 years old. For children with non-severe asthma, follow-up visits will be once a year, focusing on their health and lung function. The study aims to follow children from childhood right through to adulthood to see how their asthma changes over time.

Potential risks and benefits

Participating in this study could help future generations of children with asthma by improving our understanding of severe forms of the condition and leading to better treatments. Your child's identity will be kept private. The extra assessments might involve a bit more time than a regular doctor's visit and some blood tests, which can be uncomfortable for a short while. For a small number of children, a more in-depth procedure might be suggested, which carries its own very small risks, and this would be fully explained beforehand. You and your child are free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (1)

Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades
Verified postcode
Paris, France

Common questions

What is 'severe asthma'?

Severe asthma is when asthma symptoms are still very bad and difficult to control, even when someone is taking strong medicines as prescribed.

Will my child have to take new medicines as part of the study?

No, this study doesn't involve giving new medicines. It's about collecting information to understand asthma better.

How long will my child need to be in the study?

The study aims to follow children over a long time, from childhood into adulthood, to see how their asthma changes.

What happens to the blood samples they take?

Blood samples will be stored in a special bank for DNA and serum (a part of blood) to be used for future research into asthma.

Will I find out the results of my child's individual tests?

You will get information about your child's regular health checks, just like during normal care. The study is for research, so detailed individual results might not always be shared.