Experimental Lung Inflammation Clinical Trial
Official title:
Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment
The purpose of this study is to investigate the local and systemic inflammatory response and
haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to
determine the feasibility of imaging techniques to quantify lung inflammation in an adapted
human endotoxin instillation model.
The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 19 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject). - Nonsmoker - Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant - If female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method) - Negative urine pregnancy test Exclusion Criteria: - Known or suspected allergy to trial product or related products - Pregnancy or Lactation - Treatment with an investigational drug within three weeks prior to this trial - Participation in an LPS trial within the last 6 weeks - Smoking - History of relevant cardiac arrhythmia - Preexisting open or closed angle glaucoma - History of Osteoporosis, Cushing´s syndrome, gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of neurosurgery - Systemic tuberculosis - Hemorrhagic diathesis - Relevant liver or kidney dysfunction - Regular use of medication or abuse of alcohol unless considered clinically relevant - Use of any medication within one week prior to the first trial day - Symptoms of a clinically relevant illness in the 3 weeks before the first trial day - Excessive sporting activities - Rosacea - Subjects on Monoamine oxidase inhibitors (should be stopped for at least two to three weeks before dihydrocodeine treatment is initiate) - Known acute or active hepatic disease within the past 3 months - A platelet count < 100,000 x 106/L, prothrombin time > 1.5, liver enzymes> 3 times the upper normal limit - Having received a vaccination up to 8 weeks before the trial |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Austria | Department of Clinical Pharmacology, Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified. | 6/24 hours after LPS Instillation | No |