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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bernd Jilma, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01714427
First received: September 6, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Experimental Lung Inflammation
Drug: Dexamethasone
Drug: Sterile isotonic saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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. [ Time Frame: 6/24 hours after LPS Instillation ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone Drug: Dexamethasone
Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.
Placebo Comparator: Sterile isotonic saline Drug: Sterile isotonic saline
two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714427

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Bernd Jilma, MD Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria
  More Information

No publications provided

Responsible Party: Bernd Jilma, Associate Professor of Clinical Pharmacology & Internal Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01714427     History of Changes
Other Study ID Numbers: DEXA - LIM
Study First Received: September 6, 2011
Last Updated: April 23, 2013
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Additional relevant MeSH terms:
Inflammation
Pneumonia
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Glucocorticoids
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014