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

Primary Purpose

Experimental Lung Inflammation

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Dexamethasone

Sterile isotonic saline

About this trial

This is an interventional basic science trial for Experimental Lung Inflammation

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Sterile isotonic saline

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01714427

First Posted

September 6, 2011

Last Updated

April 23, 2013

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01714427

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Experimental Lung Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Title

Sterile isotonic saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sterile isotonic saline

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernd Jilma, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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

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