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

NCT ID: NCT01714427

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

Conditions

Experimental Lung Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Dexamethasone

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.

Sterile isotonic saline

Group Type: PLACEBO_COMPARATOR

Sterile isotonic saline

Intervention Type: DRUG

two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.

Interventions

Dexamethasone

Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.

Intervention Type: DRUG

Sterile isotonic saline

two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Bernd Jilma

Associate Professor of Clinical Pharmacology & Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernd Jilma, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

DEXA - LIM

Identifier Type: -

Identifier Source: org_study_id