Health Condition 1: null- Idiopathic Pulmonary Fibrosis
Conditions
Interventions
Intervention1: Nintedanib: Will receive nintedanib 150mg twice daily orally for 24 weeks
Control Intervention1: Nintedanib and Sildenafil: Will receive nintedanib 150mg twice daily orally for 24 weeks
Sponsors
Boehringer Ingelheim
Eligibility
Inclusion criteria
Inclusion criteria: 1 Written informed consent consistent with ICH-GCP and local laws signed prior to any study procedures being performed including any required washout 2 Male or female patients aged more than or equal to 40 years at visit 1 3 A clinical diagnosis of IPF within the last 6 years before visit 1 based upon the ATS ERS JRS ALAT 2011 guideline 4 Combination of high resolution computed tomography HRCT pattern and if available surgical lung biopsy pattern consistent with a diagnosis of IPF as assessed by the investigator based on a HRCT scan performed within 18 months of visit 1 5 DLCO corrected for Hb less than or equal to 35 percent predicted of normal at visit 1
Exclusion criteria
Exclusion criteria: 1 Previous enrolment in this trial 2 ALT AST more than 1.5 fold upper limit of normalat visit 1 3 Total bilirubin more than 1.5 fold ULN at visit 1 4 Relevant airways obstruction pre-bronchodialator FEV1/FVC less than 0.7 at visit 1 5 History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1 6 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 event within 12 months prior to visit 1 History of haemoptysis or haematuria active gastrointestinal bleeding or ulcers and or major injury or surgery within 3 months prior to visit 1 International normalised ratio more than 2 at visit 1 Prothrombin time and activated partial thromboplastin time more than 150 percent of institutional ULN at visit 1 7 Planned major surgery during the trial participation including lung transplantation major abdominal or major intestinal surgery 8 History of thrombotic event within 12 months of visit 1 9 Creatinine clearance less than 30 mL per min calculated by CockcroftGault formula 10 Presence of aortic stenosis per investigator judgement at visit 1 11 Severe chronic heart failure defined by left ventricular ejection fraction per investigator judgement at visit 1 12 Presence of idiopathic hypertrophic subaortic stenosis (IHSS) per investigator judgement at visit 1 13 Second-degree or third-degree atrioventricular (AV) block on electrocardiogram (ECG) per investigator judgement at visit 1 14 Hypotension (systolic blood pressure [SBP] [DBP] 15 Uncontrolled systemic hypertension (SBP > 180 mmHg; DBP > 100 mmHg) at visit 1 16 Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose to priapism 17 Retinitis pigmentosa 18 History of vision loss 19 History of nonarteritic ischemic optic neuropathy 20 Veno-occlusive disease 21 History of acute IPF exacerbation or respiratory infection within 8 weeks of visit 2 22 Treatment with nitrates, n-acetylcysteine, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, prednisone >15 mg daily or >30 mg every 2 days OR equivalent dose of other oral corticosteroids as well as any investigational drug within 4 weeks of visit 2 23 Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol, treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil) or a stimulator of guanylatcyclase (e.g., riociguat) within 4 weeks of visit 2 24 Treatment with potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir within 4 weeks of visit 2 25 Supplementation with L-arginine and concurrent use of grapefruit juice or St Johnâ??s wort within 4 weeks of visit 2 26 Treatment with the reduced dose of nintedanib (100 mg bid) within 4 weeks of visit 2 27 Permanent discontinuation of nint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SGRQ total scoreTimepoint: 12 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in dyspnea using UCSD SOBQ Change from baseline in SGRQ total score Change from baseline in dyspnea using UCSD SOBQ Percentage of patients with on-treatment SAEs from baselineTimepoint: 24 Week | — |
Countries
Australia, Belgium, Canada, China, France, Germany, India, Italy, Japan, Mexico, Spain, United Kingdom, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Private Limited
Outcome results
None listed