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 17-0003

Principal Investigator(s)
Maria L Padilla

Department(s) or Division(s)
Pulmonary, Critical Care and Sleep Medicine

Description

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.



Contact Information
Diana Valerio
(212) 241-9538
diana.valerio@mssm.edu

Recruiting Patients: Yes