Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI 3720931 (Lenticlair™-ON)

This is a long-term health study for people with cystic fibrosis who have already taken part in a previous trial involving a medicine called BI 3720931. The main aim is to keep an eye on the health of these participants over many years, to understand the long-lasting effects of the medicine. Participants in this study will not be given new doses of BI 3720931. If you previously received the active medicine, your health will be checked regularly for up to 15 years. If you received a dummy medicine (placebo) in the earlier trial, you will be in this study only until it is revealed you were in that group. The study will involve regular check-ups and lung function tests to monitor your health.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Boehringer Ingelheim

Enrolment target

Start

20 May 2025

Estimated completion

29 Oct 2040

Cystic Fibrosis

What is this study about?

This study is designed for adults with cystic fibrosis who previously took part in an earlier research study involving a medicine called BI 3720931 (also known as Lenticlair™-ON). The main goal of this new study is to closely follow your health over a long period. We want to understand what happens to people's health in the years after they have been part of a trial for this specific medicine.

It's important to know that if you join this study, you will not receive any more doses of the BI 3720931 medicine. This study is purely about observing and monitoring your health. The information gathered will help doctors and researchers understand the long-term effects of the medicine. This is crucial for knowing if the medicine is safe and if it helps people with cystic fibrosis stay healthier over time.

By carefully watching how participants are doing, including checking their lung function and any health issues, researchers can build a complete picture of the medicine's impact. This kind of follow-up study is a very important step in developing new treatments, as it helps ensure that new medicines are not only effective but also safe for people to use for many years.

Key takeaways

A long-term study for adults with cystic fibrosis.
Only for those who participated in a previous BI 3720931 trial.
No new medication is given in this study.
Focuses on monitoring long-term health and lung function.
Participation can last up to 15 years for some.
Helps understand the long-term effects of the medicine.

Who may be eligible?

To take part in this study, you must have already been a participant in an earlier study sponsored by the same company (BI) that involved the medicine BI 3720931.

This means you must have previously received either the actual medicine (BI 3720931) or the dummy medicine (placebo) during that first study. You also need to be willing to sign a consent form, which means you understand what the study involves and agree to take part voluntarily.

Quick self-check

Did you take part in a previous BI-sponsored study for BI 3720931?
Were you an adult (18 years or older) when you joined that previous study?
Are you willing to sign a form that says you understand and agree to take part?
Were you given either BI 3720931 or the dummy medicine (placebo) in the previous study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will not be given any new medication. Your involvement will depend on what you received in the previous trial. If you received BI 3720931 earlier, you'll be part of this study for up to 15 years. You will have regular appointments at the study site, visiting once every three months for the first two years, and then once a year after that. In total, you might have around 20 visits.

During these visits, doctors will check your general health and write down any health problems you might be having. They will also carry out special tests to check how well your lungs are working. This helps them understand the long-term effects of the BI 3720931 medicine. If you received the dummy medicine (placebo) in the earlier trial, you will only be in this study until the researchers tell you which treatment you received before. Once this information is shared, your participation in this follow-up study will end.

Potential risks and benefits

The potential benefits of taking part in this study are that you would receive regular health check-ups and monitoring by medical professionals. This contributes to important knowledge about cystic fibrosis and potential long-term treatments, which could help future patients. As you won't be receiving new medication in this study, the direct risks from the medicine itself are not applicable. However, there are always minor risks associated with study visits, such as the time commitment and travel. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Hôpital Gui de Chauliac
Montpellier, France
Osp. Pediatrico Bambin Gesù
Roma, Italy
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Royal Brompton Hospital
London, United Kingdom

Common questions

What is the main purpose of this study?

The main purpose is to monitor the long-term health of people with cystic fibrosis who previously took part in a trial for a medicine called BI 3720931.

Will I receive any new medicine in this study?

No, you will not receive any additional doses of BI 3720931 in this study. It's purely for health monitoring.

How long will I be in the study?

If you received the active medicine previously, you will be in the study for up to 15 years. If you received the dummy medicine (placebo), you'll be in it until you find out which treatment you had.

What will happen during study visits?

Doctors will check your health and do lung function tests to see how you are doing and note any health changes.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.