Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment

Inclusion criteria:

- Written informed consent consistent with International Conference on Harmonisation
Good Clinical Practice and local laws, signed prior to participation in the trial
including any study related procedures being performed;

- Male or female patients aged >=40 years at Visit 1;

- A clinical diagnosis of Idiopathic pulmonary fibrosis (IPF) within the last 3 years
from visit 0, based upon the American Thoracic Society/ European Respiratory Society
/Japanese Respiratory Society/ Latin American Thoracic Association 2011 guideline;

- Chest high resolution computed tomography (HRCT) scan performed within 18 months of
Visit 0;

- Combination of HRCT pattern, and surgical lung biopsy pattern (the latter if
available) as assessed by central review are consistent with the diagnosis of
Idiopathic pulmonary fibrosis;

- Forced vital capacity (FVC) >=80% of predicted normal at Visit 1.

Exclusion criteria:

- Alanine transaminase, Aspartate aminotransferase > 1.5 fold upper limit of normal
(ULN) at Visit 1;

- Total bilirubin > 1.5 fold ULN at Visit 1;

- Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic
impairment);

- Relevant airways obstruction, i.e. pre-bronchodilator Forced expiratory volume in 1
second / Forced vital capacity < 0.70;

- History of myocardial infarction within 6 months of visit 1 or unstable angina within
1 month of Visit 1;

- Bleeding Risk:

- Known genetic predisposition to bleeding;

- Patients who require fibrinolysis, full-dose therapeutic anticoagulation or high
dose antiplatelet therapy;

- History of haemorrhagic central nervous system (CNS) event within 12 months prior
to Visit 1;

- History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers
and/or major injury or surgery within 3 months prior to Visit 1;

- International normalised ratio (INR) > 2 at Visit 1;

- Prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of ULN at
Visit 1;

- Planned major surgery during the trial participation, including lung transplantation,
major abdominal or major intestinal surgery;

- History of thrombotic event (including stroke and transient ischemic attack) within 12
months of Visit 1;

- Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula at Visit 1;

- Treatment with nintedanib, pirfenidone, azathioprine, cyclophosphamide, cyclosporine,
any other investigational drug, n-acetylcysteine, prednisone/prednisolone >15 mg daily
or >30 mg every 2 days OR use of other systemic corticosteroids as well as any
investigational drugs within 4 weeks of Visit 2;

- Known hypersensitivity to nintedanib, peanut, soya or to any other components of the
study medication;

- Prior discontinuation of nintedanib treatment due to intolerability/ adverse events
considered drug related;

- A disease or condition which in the opinion of the investigator may interfere with
testing procedures or put the patient at risk when participating in this trial;

- Alcohol or drug abuse which in the opinion of the treating physician would interfere
with the treatment and would affect patient's ability to participate in this trial;

- Patients not able to understand and follow any study procedures such as but not
limited to home spirometry, including completion of self-administered questionnaires
without help;

- Women who are pregnant, nursing, who plan to become pregnant while in the trial or
female patients with positive pregnancy (ß-HCG) test at Visit 1 and/or Visit 2;

- Women of childbearing potential4 not willing or able to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
year when used consistently and correctly.

- Patients with acute IPF exacerbation or any respiratory tract infection in the four
weeks prior to Visit 1 or during the screening period;

- Patients who are or have been participating in another trial with investigational
drug/s within one month prior to Visit 1 and patients who have previously been
enrolled in this trial;

- Further exclusion criteria apply.