Evaluating Nerandomilast to Slow Lung Changes in Adults 40 and Older with Family History of Pulmonary Fibrosis and Early Lung Abnormalities

What this Trial Is About

Researchers are studying adults aged 40 years or older who have at least one family member with pulmonary fibrosis, a condition that causes scarring in the lungs and makes breathing difficult. The trial aims to find out if a drug called nerandomilast can slow lung changes in people showing early lung abnormalities on scans. This study is a Phase 3 clinical trial involving participants who have early signs of lung scarring and a family history of pulmonary fibrosis. Participants are randomly assigned to one of two groups one group takes nerandomilast tablets, and the other takes placebo tablets that look the same but contain no medicine. They take a tablet twice daily for about 2 to 3 years. During the study, there is a 60% chance a participant will receive nerandomilast. The trial lasts approximately 2 to 3 years, with more frequent visits every three months during the first two years and then every six months, plus phone calls in the third year. Throughout the study, doctors regularly test lung function and perform chest scans to monitor lung changes and the effects of treatment. Health status and any unwanted effects are also checked. The main outcome measured is the time to worsening of lung abnormalities over the trial period. Participants will be followed closely with lung function tests, imaging, and health assessments to understand the impact of nerandomilast compared to placebo.

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis