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

NCT01714427 | Completed DMC

• 1 other identifier: DEXA - LIM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone

Sterile isotonic saline

PLACEBO COMPARATOR

Drug: Sterile isotonic saline

Interventions

Dexamethasone DRUG

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

Dexamethasone

Sterile isotonic saline DRUG

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

Sterile isotonic saline

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bernd Jilma, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pharmacology & Internal Medicine

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: October 26, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

AU (1)