- Conditions
- Idiopathic Pulmonary FibrosisMedDRA version: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-024252-29-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 794
Patient aged ? 40 years
IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline (in press) for diagnosis and management, within 5 years of visit 2.
Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
Dlco (corrected for Hb [visit 1]): 30%-79% predicted of normal
FVC ? 50% predicted of normal
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 151
Laboratory parameters AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN.
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7).
In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation).
Myocardial infarction within 6 months of visit 2.
Unstable angina within 1 month of visit 2.
Bleeding risk (Known genetic predisposition, fibrinolysis, full-dose therapeutic anticoagulation or high dose antiplatelet therapy, history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery.
Thrombotic risk (known inherited predisposition to thrombosis, history of thrombotic event (including stroke and transient ischemic attacks) within 12 months, International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN.
NAC, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1.
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The annual rate of decline in FVC (expressed in ml during 52 weeks);Timepoint(s) of evaluation of this end point: -;Main Objective: The primary objective is to demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).;Secondary Objective: To assess the patient?s perception of his/her disease, and the time to IPF exacerbation.<br>To investigate respiratory and overall survival, as well as causes of mortality.<br>To assess safety and tolerability.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -