5 results
The aim of this extension trial is to provide BIBF 1120 treatment for all patients who have completed the 52 weeks treatment period and the follow up period in the phase III placebo controlled parent trial 1199.34, who may have experienced benefit…
to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
The primary objective of this study is to evaluate efficacy and safety. Secondary objectives: PK, PK-PD.
The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.