Condition category
Respiratory
Date applied
16/02/2006
Date assigned
28/04/2006
Last edited
10/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Guenther

ORCID ID

Contact details

Department of Internal Medicine
Klinikstr. 36
Giessen
35392
Germany
+49 (0)6 4142 502
andreas.guenther@innere.med.uni-giessen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DOSEFIB 18-NOV-05

Study information

Scientific title

Acronym

DOSEFIB

Study hypothesis

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

Approved by the Ethics Committee of the School of Medicine, Justus-Liebig-University Giessen, Germany on 21/02/2006, reference number: 11/06

Study design

Open label, single site

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Idiopathic Pulmonary Fibrosis

Intervention

Triple daily inhalation of 10,000 up to 24,000 units of unfractioned heparin

Intervention type

Drug

Phase

Not Specified

Drug names

Heparin

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/03/2006

Recruitment end date

01/08/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Internal Medicine
Giessen
35392
Germany

Sponsor information

Organisation

Individual Sponsor (Germany)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

German Research Council (Deutsche Forschungsgemeinschaft) (DFG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes