Stopped: Unable to enroll any subjects. IRB closed study in agreement with PI.
Assess efficacy (as measured by annual rate of decline in FVC) and safety. The hypothesis is that nintedanib will be safe and effective therapy for patients with progressive fibrosing CMD-ILD over a period of 52 weeks. Test Article - Nintedanib 150 mg administered PO twice daily or matching placebo. A total of 160 patients meeting inclusion/exclusion criteria will be randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily. A randomization scheme will be used that balances the group for potential confounders (proportion with PMF or small opacity-only PF-CMD\_ILD and proportion of ever- or never-smokers). The dose of the study drug may be reduced to 100 mg twice daily or interrupted temporarily to manage adverse events (AEs).
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Annual rate of decline in FVC in mL (absolute)
Timeframe: Baseline after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Timeframe: 12 weeks after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Timeframe: 24 weeks after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Timeframe: 36 weeks after first drug intake (planned post visits with Spirometry test)
Annual rate of decline in FVC in mL (absolute)
Timeframe: 52 weeks after first drug intake (planned post visits with Spirometry test)