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)

Launched by BOEHRINGER INGELHEIM · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to monitor the long-term health of people with cystic fibrosis who participated in a previous study involving a medicine called BI 3720931 (also known as Lenticlair™-ON). The main goal is to see how participants' health has changed over time after receiving either the medicine or a placebo (a treatment that has no active ingredients). If you took BI 3720931 in the earlier study, you’ll be followed for 15 years, with regular check-ups about every three months for the first two years and then once a year after that. If you were in the placebo group, you'll be part of the study until it’s revealed that you received the placebo, at which point you’ll stop participating.

To join this trial, you need to have previously taken BI 3720931 or the placebo in the earlier study and be willing to give your consent to participate. During visits, doctors will check your health, look for any issues that might be related to the treatment, and perform lung function tests to see how well your lungs are working. This study is not yet recruiting participants, but it’s important for understanding the long-term effects of BI 3720931 on people with cystic fibrosis.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Trial participants who participated in a previous BI sponsored trial with BI 3720931 and have received any dose of BI 3720931, or matching placebo
• • 2. Signed and dated written informed consent in accordance with International Council for Harmonisation (ICH)-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
• • There are no exclusion criteria for enrolment into the trial.