<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714427</url>
  </required_header>
  <id_info>
    <org_study_id>DEXA - LIM</org_study_id>
    <nct_id>NCT01714427</nct_id>
  </id_info>
  <brief_title>Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment</brief_title>
  <official_title>Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the local and systemic inflammatory response and&#xD;
      haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to&#xD;
      determine the feasibility of imaging techniques to quantify lung inflammation in an adapted&#xD;
      human endotoxin instillation model.&#xD;
&#xD;
      The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>6/24 hours after LPS Instillation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Experimental Lung Inflammation</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sterile isotonic saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sterile isotonic saline</intervention_name>
    <description>two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.</description>
    <arm_group_label>Sterile isotonic saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained before any trial-related activities. (Trial&#xD;
             activities are any procedure that would not have been performed during normal&#xD;
             management of the subject).&#xD;
&#xD;
          -  Nonsmoker&#xD;
&#xD;
          -  Normal findings in medical history and physical examination unless the investigator&#xD;
             considers an abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Normal laboratory values unless the investigator considers an abnormality to be&#xD;
             clinically irrelevant&#xD;
&#xD;
          -  If female and of childbearing potential and subjects agrees to employ adequate birth&#xD;
             control measures (e. g. oral contraceptives, barrier method)&#xD;
&#xD;
          -  Negative urine pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected allergy to trial product or related products&#xD;
&#xD;
          -  Pregnancy or Lactation&#xD;
&#xD;
          -  Treatment with an investigational drug within three weeks prior to this trial&#xD;
&#xD;
          -  Participation in an LPS trial within the last 6 weeks&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  History of relevant cardiac arrhythmia&#xD;
&#xD;
          -  Preexisting open or closed angle glaucoma&#xD;
&#xD;
          -  History of Osteoporosis, Cushing´s syndrome, gastro-duodenal ulcera, cardiovascular&#xD;
             disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of&#xD;
             neurosurgery&#xD;
&#xD;
          -  Systemic tuberculosis&#xD;
&#xD;
          -  Hemorrhagic diathesis&#xD;
&#xD;
          -  Relevant liver or kidney dysfunction&#xD;
&#xD;
          -  Regular use of medication or abuse of alcohol unless considered clinically relevant&#xD;
&#xD;
          -  Use of any medication within one week prior to the first trial day&#xD;
&#xD;
          -  Symptoms of a clinically relevant illness in the 3 weeks before the first trial day&#xD;
&#xD;
          -  Excessive sporting activities&#xD;
&#xD;
          -  Rosacea&#xD;
&#xD;
          -  Subjects on Monoamine oxidase inhibitors (should be stopped for at least two to three&#xD;
             weeks before dihydrocodeine treatment is initiate)&#xD;
&#xD;
          -  Known acute or active hepatic disease within the past 3 months&#xD;
&#xD;
          -  A platelet count &lt; 100,000 x 106/L, prothrombin time &gt; 1.5, liver enzymes&gt; 3 times the&#xD;
             upper normal limit&#xD;
&#xD;
          -  Having received a vaccination up to 8 weeks before the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernd Jilma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 6, 2011</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 23, 2013</last_update_submitted>
  <last_update_submitted_qc>April 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Bernd Jilma</investigator_full_name>
    <investigator_title>Associate Professor of Clinical Pharmacology &amp; Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714427
org study id: DEXA - LIM
nct id: NCT01714427
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: 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
arm group label: Dexamethasone
arm group type: Active Comparator
arm group label: Sterile isotonic saline
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Dexamethasone
description: Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.
arm group label: Dexamethasone
intervention type: Drug
intervention name: Sterile isotonic saline
description: two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.
arm group label: Sterile isotonic saline
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bernd Jilma, MD
role: Principal Investigator
affiliation: Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Bernd Jilma
investigator title: Associate Professor of Clinical Pharmacology & Internal Medicine
mesh term: Pneumonia
mesh term: Inflammation
mesh term: Dexamethasone