Idiopathic Pulmonary Fibrosis Respiratory Idiopathic Pulmonary Fibrosis
Conditions
Interventions
Triple daily inhalation of 10,000 up to 24,000 units of unfractioned heparin
Sponsors
Individual Sponsor (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with idiopathic pulmonary fibrosis (IPF) according to consensus criteria 2. Age between 18 and 70 3. Completion of physical examination 4. Body weight of more than 40 kg 5. 40% 55 mmHg (with or without O2) 8. Signed informed consent 9. Requirements of Local Ethics Committee are met
Exclusion criteria
Exclusion criteria: 1. Any hemoptysis of unknown reason 2. Any significant and otherwise unexplainable bleeding with reduction of hemoglobin values by more than 10% in patient’s history 3. Pre-existing presence of heparin induced antibodies 4. Preceding surgery within last 6 weeks 5. Current gastric or duodenal ulcer or inflammatory bowel disease 6. Any oesophageal varicosis of any size 7. Current colon adenoma with previous gastrointestinal bleeding 8. Current lower respiratory tract infection with CRP >10 mg/l 9. Any suspected or proven active malignancy, especially lung cancer 10. Any need for systemic anticoagulation with International Normalized Ratio (INR) >1.5 11. Any treatment with another investigational drug 12. Acute or chronic left heart failure 13. Severe arterial hypertension (>200 mmHg systolic or >120 mmHg diastolic) 14. Inherited or acquired coagulation disorders resulting in prolonged bleeding time or an INR >1.5 15. Disseminated intravascular coagulation 16. Deficient thrombocyte function or platelet counts 10 mg%) 20. Renal insufficiency with creatinine values >3mg% or proteinuria >1 g per day 21. Primary or secondary immunodeficiency 22. Previous therapeutic radiation of the lungs or the mediastinum 23. Elevated intracranial pressure 24. Pregnancy, breast feading or lack of safe contraception 25. Patients whose underlying disease is not likely to permit them to survive the study - any hemoptysis of unknown reason 26. Sickle cell anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as based on the following five safety events: 1. Any otherwise unexplainable decline in forced vital capacity by more than 10% 2. Any otherwise unexplainable decline in diffusion capacity by more than 10% 3. Any otherwise unexplainable decline in 6 min walking distance by more than 20% 4. Any otherwise unexplainable decline in serum hemoglobin by more than 10% 5. Any occurrence of hemoptysis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of heparin induced antibodies 2. Recalcification times of bronchoalveolar lavage (BAL) fluids obtained at end of study 3. Change in capillary oxygen partial pressure 4. Change in oxygen saturation | — |
Countries
Germany
Outcome results
None listed