Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31). Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
150 mg bid
Existing treatment
Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan
Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
Incidence of Overall Adverse Events
Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.
Time frame: First drug administration until end of treatment, up to 5 years
Annual Rate of Decline in Forced Vital Capacity (FVC).
The adjusted annual rate of decline in Forced Vital Capacity (FVC). The means presents actually the adjusted rate based on a random coefficient regression with fixed effects for gender, age, height and random effect of patient specific intercept and time. Within-patient errors are modelled by an Unstructured variance-covariance matrix. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix. The result for Annual rate of decline (ROD) in FVC should be interpreted with caution and along with descriptive statistics, because inferences used for this analysis might not be valid as suggested by skewed distribution of the data.
Time frame: Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years
Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Adjusted annual rate of decline in Hb corrected DLCO. The means presents actually adjusted rate based on random coefficient regression with fixed effects for gender, age, height \& random effect of patient specific intercept \& time. Within-patient errors are modelled by Unstructured variance-covariance matrix.Inter-individual variability is modelled by a variance-Components variance-covariance matrix. mmHg: millimeters of mercury
Time frame: Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years
Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.
The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.
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Time frame: First drug administration until end of treatment, up to 5 years
Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.
The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.
Time frame: Week 234