Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
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) (NCT00514683), 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 high dose of 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 high dose 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 globally accepted for assessment of treatment effects in IPF
patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is
part of the usual examinations done in IPF patients.