Dose-finding and safety of heparin aerosol application in idiopathic pulmonary fibrosis
| ISRCTN | ISRCTN43849290 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43849290 |
| Secondary identifying numbers | DOSEFIB 18-NOV-05 |
- Submission date
- 16/02/2006
- Registration date
- 28/04/2006
- Last edited
- 03/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andreas Guenther
Scientific
Scientific
Department of Internal Medicine
Klinikstr. 36
Giessen
35392
Germany
| Phone | +49 (0)6 4142 502 |
|---|---|
| andreas.guenther@innere.med.uni-giessen.de |
Study information
| Study design | Open label, single site |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Dose-finding and safety of heparin aerosol application in idiopathic pulmonary fibrosis |
| Study acronym | DOSEFIB |
| Study objectives | To identify suitable amounts of inhaled heparin that result in a prolonged alveolar anticoagulatory activity and to assess safety and tolerability of such heparin treatment in a period of 4 weeks |
| Ethics approval(s) | Approved by the Ethics Committee of the School of Medicine, Justus-Liebig-University Giessen, Germany on 21/02/2006, reference number: 11/06 |
| Health condition(s) or problem(s) studied | Idiopathic Pulmonary Fibrosis |
| Intervention | Triple daily inhalation of 10,000 up to 24,000 units of unfractioned heparin |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Heparin |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/03/2006 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 19 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Internal Medicine
Giessen
35392
Germany
35392
Germany
Sponsor information
Individual Sponsor (Germany)
University/education
University/education
c/o Werner Seeger
University of Giessen Lung Center
Director of the Department of Respiratory and Critical Care Medicine
Klinikstrasse 36
Giessen
D-35392
Germany
Funders
Funder type
Government
German Research Council (Deutsche Forschungsgemeinschaft) (DFG)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | 03/05/2019 | Yes | No |
Editorial Notes
03/05/2019: Publication reference and total final enrolment added.
