Official Title
Medical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiopathic Pulmonary Fibrosis) Chronic Fibrosing Interstitial Lung Diseases (ILDs) With a Progressive Phenotype (PF-ILD's)
Brief Summary

This Expanded Access Program in Belgium is open to people with different lung diseases. This program provides a medicine called nintedanib to people who have no alternative treatment options. They can participate if they have a type of lung disease called non-IPF ILDs (chronic fibrosing interstitial lung diseases with a progressive phenotype other than idiopathic pulmonary fibrosis). Participants take 2 capsules of nintedanib a day. The treating physician checks the health of the participants and notes health problems that could have been caused by nintedanib. Participants receive nintedanib as long as they benefit or until nintedanib becomes commercially available in Belgium. For a patient to participate in this program, their treating physician should apply to Boehringer Ingelheim.

Available
Intermediate-size Population
Lung Diseases, Interstitial

Drug: nintedanib
nintedanib
Other Name: Ofev®

Eligibility Criteria

Inclusion Criteria: - The patient is not eligible for a clinical trial running with Ofev® and/or a clinical trial running in the envisaged indication of this program. - The patient cannot be satisfactorily treated with the approved and commercially available alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues. - Signed informed consent form - Age ≥ 18 years - Patients diagnosed with ILD who fulfilled at least 1 of the following criteria for PF-ILD within 24 months prior to inclusion in this Medical Need Program (MNP): - Clinically significant decline in Forced Vital Capacity (FVC) % predicted based on a relative decline of ≥10% - Marginal decline in FVC % predicted based on a relative decline of ≥5 to

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Contacts

Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Boehringer Ingelheim
NCT Number
MeSH Terms
Lung Diseases
Lung Diseases, Interstitial
Nintedanib
Intervention Name
nintedanib