1199.32 - A phase III study of oral BIBF 1120 in patients with IPF
Research type
Research Study
Full title
A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
73678
Contact name
Toby Maher
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2010-024251-87
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with 150 mg bid BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a dose of 150mg in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is an accepted endpoint for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity decline) is easy to obtain and is part of the usual examinations done in IPF patients
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
11/EM/0053
Date of REC Opinion
28 Apr 2011
REC opinion
Further Information Favourable Opinion