A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
This study is for children and young people aged 2 to 17 who have a lung condition called interstitial lung disease (ILD). A medicine called Nerandomilast has recently been approved for adults with a similar lung problem. This study aims to find out if Nerandomilast is safe, how the body handles it, and if it can help children and young people with ILD. Some participants will receive the active medicine, while others might get a placebo (a dummy pill with no medicine) at first, chosen by chance. The study involves taking medicine daily, regular check-ups, and tests over several years to see how participants respond and if their lung health improves. All participants will eventually receive the active medicine.
At a glance
What is this study about?
This study, called FIBRONEER-chILD, is looking into a new medicine called Nerandomilast for children and teenagers aged 2 to 17 who have a lung condition known as interstitial lung disease (ILD). This condition causes scarring in the lungs, making it harder to breathe. Nerandomilast has just been approved in some parts of the world to help adults with a similar lung problem called idiopathic pulmonary fibrosis. The main aim of this study is to understand if this medicine is safe for younger people, how their bodies use it, and most importantly, if it can help improve their lung health.
For participants aged 6 to 17, the study is split into two parts. In the first part, which lasts for six months, participants are randomly placed into one of two groups. One group will receive the actual Nerandomilast medicine, and the other will receive a placebo, which looks exactly like the medicine but contains no active ingredients. It's important to know that two out of three participants in this age group will get Nerandomilast in this first stage. After these six months, everyone, regardless of what they received initially, will get Nerandomilast for at least two more years. Younger participants, aged 2 to 5, will receive Nerandomilast from the very beginning of the study, taking the medicine for at least two and a half years.
The study will involve regular visits to a clinic over several years, ranging from two and a half to five years depending on when a person joins. During these visits, doctors will closely monitor participants' health. This includes taking blood samples to understand how the body processes the medicine, checking how well the lungs are working, monitoring growth, and asking how participants are feeling. These regular checks are vital to see if the medicine is making a difference and to keep everyone safe.
Key takeaways
- New medicine for children (2-17) with fibrosing ILD.
- Aims to check safety, body handling, and effectiveness.
- Some participants might get a placebo first, others get medicine straight away.
- Involves daily medicine and regular clinic visits over several years.
- Close monitoring of lung function and overall health.
Who may be eligible?
This study is looking for children and young people between 2 and under 18 years old. To join, your doctors need to have seen signs of scarring in your lungs (fibrosing ILD) on a special scan called a HRCT within the last year. For those aged 6 and over, their lung function, measured by something called FVC, needs to be at a certain level. Doctors also need to agree that your ILD is causing significant problems, which might be shown by certain scores, or if your lung function has gotten worse over time, or if your need for oxygen has increased.
There are also some reasons why you might not be able to join. For example, if you've already taken Nerandomilast, or if you've taken certain other lung medicines in the weeks before the study starts. You also wouldn't be able to join if you have certain other serious health issues, like unstable high blood pressure in the lungs, or specific mental health concerns related to suicidal thoughts or severe depression.
It's important to remember that there are other specific things doctors look at, both for who can join and who cannot. Your doctor will be able to check all these details to see if this study is suitable for 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.
- Are you between 2 and 17 years old?
- Has a recent scan (HRCT) shown scarring in your lungs?
- For ages 6+, is your lung function (FVC) at a certain level?
- Are your doctors concerned about your ILD getting worse?
- Have you *not* taken Nerandomilast before?
What does participation involve?
If you decide to take part in this study, the total time you'll be involved can range from two and a half years to up to five years, depending on when you start. During this period, you will need to come to the study clinic about 18 to 30 times for check-ups and tests.
For those aged 6 to 17, the first six months will involve taking either the study medicine (Nerandomilast) or a placebo (a dummy pill) twice a day. After these six months, everyone in this age group will receive Nerandomilast for at least two years. If you are aged 2 to 5, you will receive Nerandomilast from the very start, also twice a day, for at least two and a half years.
During your visits, study doctors will perform several assessments. This includes taking blood samples to monitor your overall health and to see how your body processes the medicine. They will also check your lung function, your growth, and talk to you about how you are feeling. The medical team will regularly monitor your health and note any changes throughout the study.
Potential risks and benefits
Locations (46)
- Children's Hospital Los AngelesVerified postcodeLos Angeles, United States
- Children's Hospital ColoradoVerified postcodeAurora, United States
- Johns Hopkins HospitalVerified postcodeBaltimore, United States
- Boston Children's HospitalVerified postcodeBoston, United States
- University of MinnesotaVerified postcodeMinneapolis, United States
- Nationwide Children's HospitalVerified postcodeColumbus, United States
- Children's Hospital of PhiladelphiaVerified postcodePhiladelphia, United States
- Fundacion RespirarUnverifiedCABA, Argentina
- Hospital de Pediatria Prof. Dr. Juan P. GarrahanUnverifiedCABA, Argentina
- Brussels - UNIV HUDERFVerified postcodeBrussels, Belgium
- Serviços Medicos Respirar Sul FluminenseVerified postcodeBarra Mansa, Brazil
- Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto DornelesVerified postcodePorto Alegre, Brazil
Common questions
What is interstitial lung disease (ILD)?
ILD is a group of lung conditions that cause scarring in the lungs, making it difficult to breathe and get enough oxygen.
What is Nerandomilast?
Nerandomilast is a new medicine that has been approved for adults with a similar lung condition. This study wants to see if it helps children and young people with ILD.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps doctors understand if the medicine itself is causing any changes or improvements.
How long will the study last for each person?
The study length can vary, but it will be at least two and a half years and could be up to five years, depending on when you join.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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