Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

Inclusion Criteria

• Patient >40 years
• Written informed consent signed prior to entry into the study
• IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit.
• HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis.
• FVC>50 % of predicted value

Predicted normal values will be calculated according to ESCS (R94-1408):

Males :

FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34

Females :

FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89

• Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .

Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.

Adjustment for haemoglobin (R06-2002):

Males :

DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb])

Females :

DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g/dL-1

• PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air

Exclusion Criteria

• AST, ALT > 1.5 x ULN ;
• Bilirubin > 1.5 x ULN
• Relevant airways obstruction
• Continuous oxygen supplementation at randomisation (defined as > 15 hours supplemental oxygen per day).
• Active infection at screening or randomisation.
• Neutrophils 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN ;
• Platelets < 100 000 /mL
• Haemoglobin < 9.0 g/dL
• In the opinion of the Investigator, patient is likely to have lung transplantation during study
• Life expectancy for disease other than IPF < 2.5 years (Investigator assessment).
• Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
• Myocardial infarction during the previous 6 months
• Unstable angina during the previous month
• Other investigational therapy received within 8 weeks prior to screening visit.
• Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment.
• Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
• Known or suspected active alcohol or drug abuse.
• Bleeding risk : Known inherited predisposition to bleeding, patients who require full-dose anticoagulation, Patients who require full-dose antiplatelet therapy, History of hemorrhagic CNS event within 12 months prior to screening , Any of the following within 3 months prior to screening : Gross / frank haemoptysis or haematuria, Active gastro-intestinal bleeding or ulcers, Major injury or surgery
• Thrombotic risk
• Surgical procedures planned to occur during trial period.
• Coagulopathy
• Uncontrolled systemic arterial hypertension
• known hypersensitivity to lactose or any component of the study medication