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

Not Applicable

Completed

• Conditions: Experimental Lung Inflammation
• Interventions: Drug: Dexamethasone; Drug: Sterile isotonic saline

• Registration Number: NCT01714427
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-26
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	-
Sterile isotonic saline	Sterile isotonic saline	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria