INSTAGE(TM):A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM)

BOEHRINGER-INGELHEIM ITALIA S.P.A.0 sites406 target enrollmentStarted: June 4, 2021Last updated: April 4, 2022

Overview

No summary available.

•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\>\=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) \<\= 35% predicted of normal at visit 1\.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 50
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Previous enrolment in this trial;
•2\. ALT, AST \> 1\.5 fold upper limit of normal (ULN) at visit 1;
•3\. Total bilirubin \> 1\.5 fold ULN at visit 1;
•4\. Relevant airways obstruction (i.e. pre\-bronchodilator FEV1/FVC \<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 (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin, etc.) 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 activated partial thromboplastin time (aPTT) \> 150% 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 (including stroke and transient ischemic attack) within 12 months of visit 1;
•9\. Creatinine clearance \< 30 mL/min calculated by Cockcroft\-Gault formula at visit 1;
•10\. Presence of aortic stenosis (AS) per investigator judgement at visit 1;

Sponsor

BOEHRINGER-INGELHEIM ITALIA S.P.A.