Nintedanib and placebo in patients with PF-ILD.
Research type
Research Study
Full 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 Disease (PF-ILD).
IRAS ID
217658
Contact name
Jill Dincki
Contact email
Sponsor organisation
Boehringer-Ingelheim
Eudract number
2015-003360-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 7 days
Research summary
This is a double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD). Patients will be assigned by random selection to receive either the investigational drug nintedanib 150mg two times daily or placebo two times daily. The duration of the treatment phase for patients will be at least 52 weeks. Approximately 25 people will participate in this study in the United Kingdom and approximately 600 participants worldwide. The primary objective is to demonstrate a reduction in lung function decline, as measured by the annual rate of decline in Forced Vital Capacity (FVC) for nintedanib compared to placebo over 52 weeks.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0044
Date of REC Opinion
3 Mar 2017
REC opinion
Further Information Favourable Opinion