Trials / Completed
CompletedNCT02999178
Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 663 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nintedanib | |
| DRUG | Placebo |
Timeline
- Start date
- 2017-01-17
- Primary completion
- 2019-04-23
- Completion
- 2019-08-12
- First posted
- 2016-12-21
- Last updated
- 2020-05-05
- Results posted
- 2020-05-05
Locations
153 sites across 15 countries: United States, Argentina, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02999178. Inclusion in this directory is not an endorsement.