Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment

Medical University of Vienna

Status

Completed

Conditions

Experimental Lung Inflammation

Treatments

Drug: Dexamethasone

Drug: Sterile isotonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01714427

DEXA - LIM

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

19 to 40 years old

Volunteers

Accepts Healthy Volunteers

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