Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment
|ClinicalTrials.gov Identifier: NCT01714427|
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : April 24, 2013
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 or disease||Intervention/treatment||Phase|
|Experimental Lung Inflammation||Drug: Dexamethasone Drug: Sterile isotonic saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Active Comparator: 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714427
|Department of Clinical Pharmacology, Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Bernd Jilma, MD||Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria|