Clinical Trial: Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disea

Brief Summary: The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Annual rate of decline in Forced Vital Capacity [ Time Frame: 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) total score at week 52 [ Time Frame: 52 weeks ]
  • Time to first acute ILD exacerbation or death over 52 weeks [ Time Frame: 52 weeks ]
  • Time to death over 52 weeks [ Time Frame: 52 weeks ]
  • Time to death due to respiratory cause over 52 weeks [ Time Frame: 52 weeks ]
  • Time to progression (defined as a equal or more than 10 percent absolute decline in Forced Vital Capacity (FVC) percent pred) or death over 52 weeks [ Time Frame: 52 weeks ]
  • Proportion of patients with a relative decline from baseline in Forced Vital Capacity (FVC) percent pred of more than 10 percent at week 52 [ Time Frame: 52 weeks ]
  • Proportion of patients with a relative decline from baseline in Forced Vital Capacity (FVC) percent pred of more than 5 percent at week 52 [ Time Frame: 52 weeks ]
  • Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score at week 52 [ Time Frame: 52 weeks ]
  • Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score at week 52 [ Time Frame: 52 weeks ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: December 19, 2016
Date Started: January 17, 2017
Date Completion: November 15, 2019
Last Updated: May 16, 2017
Last Verified: May 2017