An open-label trial of the long-term safety and tolerability of nintedanib per os, on top of standard of care, over at least 3 years, in children and adolescents with clinically significant fibrosing Interstitial Lung Disease (InPedILD®-ON)
This study is investigating a medicine called nintedanib for children and young people who have a significant fibrosing Interstitial Lung Disease (ILD). ILD is a group of conditions that can cause scarring in the lungs. This trial is open-label, meaning everyone knows they are receiving the study drug. The main goal is to understand the long-term safety of nintedanib and how well patients tolerate it over at least three years, when given alongside their current usual treatments. By carefully monitoring any side effects, researchers hope to gather important information about this medicine for a condition that affects young people.
At a glance
What is this study about?
This research study is looking at a medicine called nintedanib for children and teenagers who have a serious lung condition known as Interstitial Lung Disease (ILD). ILD isn't just one illness; it's a group of conditions that can cause scarring in the lungs, making it harder to breathe.
The main purpose of this study is to discover if nintedanib is safe and if young people can take it without too many problems over a long period, at least three years. The medicine will be given in addition to the treatments they are already receiving for their lung condition. Because this is an 'open-label' study, everyone involved, including the patients, their families, and the doctors, will know that the study medicine is nintedanib.
By carefully checking for any side effects or problems that might come up during the treatment, the researchers hope to learn important information about nintedanib. This knowledge could help doctors better care for children and teenagers with this challenging lung condition in the future.
Key takeaways
- The study investigates nintedanib for children with lung scarring.
- It checks the medicine's long-term safety over at least 3 years.
- Participants will also continue their usual treatments.
- It's an 'open-label' study, so everyone knows what medicine is given.
- The main goal is to understand side effects and how well the medicine is tolerated.
Who may be eligible?
This study is open to both boys and girls of all ages. To be considered, children and young people must have a significant type of Interstitial Lung Disease that causes scarring in the lungs.
The medical team will carefully review each potential participant to make sure they meet all the study's health requirements. This ensures the study is as safe as possible for everyone involved.
- Is my child a boy or a girl? (All genders are welcome)
- Is my child a child or a teenager? (All ages can be considered)
- Has my child been diagnosed with a significant fibrosing Interstitial Lung Disease (ILD)?
- Is my child currently receiving standard medical care for their lung condition?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, your child will receive the study medicine, nintedanib, by mouth. This will be alongside their usual medical care. The study will last for at least three years. During this time, your child will have regular visits to the hospital or clinic. These visits will involve various tests, such as lung function checks, blood tests, and physical examinations, to monitor their health and see how they are responding to the medication. The research team will explain the exact schedule of visits and what each will involve. You can stop participating at any time.
Potential risks and benefits
Locations (8)
- —Belgium
- —Portugal
- —Italy
- —Norway
- —France
- —Czechia
- —Greece
- —Poland
Common questions
What is nintedanib?
Nintedanib is a medicine being studied for certain lung conditions, including those that cause scarring.
What does 'fibrosing Interstitial Lung Disease (ILD)' mean?
This is a type of lung condition where the lungs develop scarring, making it harder to breathe and for the lungs to work properly.
What does 'open-label' mean in this study?
It means that everyone involved – the patients, their families, and the doctors – will know that the study medicine being given is nintedanib.
How long will my child be in the study?
Your child will be part of the study for at least three years, receiving the medicine and having regular check-ups.
Will my child still get their usual medicines for their lung condition?
Yes, nintedanib will be given in addition to your child's standard or usual treatments for their lung condition.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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