Dose-finding and safety of heparin aerosol application in idiopathic pulmonary fibrosis

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis; Respiratory

• Registration Number: ISRCTN43849290
• Lead Sponsor: Individual Sponsor (Germany)

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20109123 (added 03/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-28
• Study Completion: 2006-08-01
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

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% < forced vital capacity (FVC) < 90%
6. 30% < diffusing capacity of the lung for carbon monoxide (Dlco) < 75%
7. Capillary pO2 >55 mmHg (with or without O2)
8. Signed informed consent
9. Requirements of Local Ethics Committee are met

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 <40,000 /µl
17. Evidence for intracranial hemorrhage
18. Diabetic retinopathy
19. Severe hepatic insufficiency (bilirubin >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified