Health Condition 1: null- Idiopathic Pulmonary Fibrosis
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Inclusion criteria
Inclusion criteria: Age more than or equal to 40 years IPF diagnosed according to most recent American Thoracic Society European Respiratory Society Japanese Respiratory Society Latin American Thoracic Association IPF guideline for diagnosis and management within 5 years Combination of High Resolution Computerized Tomography pattern and if available surgical lung biopsy pattern as assessed by central reviewers are consistent with diagnosis of IPF Dlco that is corrected for Hb is 30%-79% predicted of normal FVC more than or equal to 50% predicted of normal
Exclusion criteria
Exclusion criteria: Aspartate Aminotransferase Alanine Aminotransferase more than 1.5 x Upper Limit of Normal ULN Bilirubin more than 1.5 x ULN Relevant airways obstruction that is pre bronchodilator FEV1/FVC less than 0.7 Patient likely to have lung transplantation during study being on transplantation list is acceptable for participation Myocardial infarction within 6 months Unstable angina within 1 month Bleeding risk that is genetic predisposition or fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy or history of hemorrhagic CNS event within 12 months haemoptysis or haematuria or active gastrointestinal bleeding or ulcers or major injury or surgery within 3 months Thrombotic risk that is inherited predisposition history of thrombotic event including stroke and transient ischemic attacks within 12 months International normalised ratio more 2, prolongation of prothrombin time and partial thromboplastin time by more than 50 percent of institutional ULN N-ACetyl Cystein, prednisone more than 15mg per day or equivalent received within 2 weeks of visit 1 Pirfenidone or azathioprine or cyclophosphamide or cyclosporine A received within 8 weeks of visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual rate of decline in FVC expressed in mL over 52 weeksTimepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute exacerbations: Proportion of patients with at least one acute exacerbation during the 52 weeks. Exacerbation days (defined by number of days with an exacerbation per patient) during the 52 weeks. Number of exacerbations during the 52 weeksTimepoint: 52 weeks;Change from baseline in Saint-George Respiratory Questionnaire (SGRQ) total score at 52 weeks (expressed in points).Timepoint: 52 weeks;Further analyses on FVC- Absolute and relative change from baseline of FVC and FVC %pred up to 52 weeks Absolute categorical change of FVC percent up to 52 weeks: decrease by more than 5, increase by more than 5, and change within equal to 5Timepoint: 52 weeks;On-treatment survival (on-treatment based on fatal adverse event + 28 days).Timepoint: 52 weeks;Overall survival (all data collected based on randomized set, including vital status follow-up, censored at 52 weeks).Timepoint: 52 weeks;Patient reported outcomes- changes in SGRQ, Shortness Of Breath Questionnaire (SOBQ), Cough And Sputum Assessment (CASAQ), Patients Global Impression of Change (PGIC), EuroQol 5-Dimensional Quality of Life Questionnaire (EQ5D), up to 52 weeksTimepoint: 52 weeks;Respiratory mortality (adjudicated; all data collected based on randomized set, including vital status follow-up, censored at 52 weeks).Timepoint: 52 Weeks;Time to death or lung transplant.Timepoint: 52 weeks;Time to first acute exacerbation (days)Timepoint: 52 weeks | — |
Countries
Australia, Belgium, Czech Republic, France, Germany, India, Ireland, Italy, United Kingdom, United States of America
Contacts
Public ContactPartha Gokhale
Boehringer Ingelheim India Pvt. Ltd.
Outcome results
None listed