A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
ID Number 17-0003Principal Investigator(s)
Maria L Padilla
Department(s) or Division(s)
Pulmonary, Critical Care and Sleep Medicine
This study is being done to:
- To see how well the study drug, called nintedanib, may help their lung disease.
- Compare the safety and effects of nintedanib with a placebo in subjects with PF-ILD.
Subjects will either get nintedanib or a placebo. A placebo looks like the study drug but has no drug in it.
Subjects may qualify to take part in this research study because they have a type of lung disease, called progressive fibrosing interstitial lung disease (PF-ILD).
Their participation in this study will last for a minimum of 1 year and may last up to 2 years depending upon when enrollment in the study worldwide is met.
Subjects will be assigned to nintedanib or placebo by random choice. Subjects have a 50% chance to receive the study drug, nintedanib, or placebo. They will have an equal chance of being placed in either of the following groups:
A. 150 mg nintedanib two times daily
B. Placebo two times daily
The number of people expected to take part in this research study at this site is 10.
Recruiting Patients: Yes