<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/NCT01703013</url>
  </required_header>
  <id_info>
    <org_study_id>KSSG-Pneumo-0001</org_study_id>
    <nct_id>NCT01703013</nct_id>
  </id_info>
  <brief_title>The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases</brief_title>
  <official_title>The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantonal Hospital of St. Gallen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hospital of St. Gallen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pathophysiology of the adrenal insufficiency of patients with critical diseases remains&#xD;
      unclear. In a prior exploratory study investigating patients with exacerbation of chronic&#xD;
      obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant&#xD;
      correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the&#xD;
      adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to&#xD;
      demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level&#xD;
      (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in&#xD;
      inflammatory lung diseases (patients with COPD and pneumonia).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Adrenal Insufficiency</condition>
  <condition>Inflammatory Lung Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood leukocytes, serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18-80 yo&#xD;
&#xD;
          -  Patients diagnosed with pneumonia or exacerbated COPD&#xD;
&#xD;
          -  Healthy controls 18-80yo&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Life threatening severe disease&#xD;
&#xD;
          -  Known primary or secondary adrenal insufficiency&#xD;
&#xD;
          -  Systemic steroid therapy in the last 8 weeks&#xD;
&#xD;
          -  Systemic therapy with opioid&#xD;
&#xD;
          -  Systemic therapy with Ketoconazol, Mitotane, Metopyron, Etomidat, Rifampicin&#xD;
&#xD;
          -  In healthy controls: relevant respiratory disease or known adrenal insufficiency or&#xD;
             indication of infection&#xD;
&#xD;
          -  Allergic reaction to ACTH&#xD;
&#xD;
          -  Missing informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 9, 2012</last_update_submitted>
  <last_update_submitted_qc>October 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation>
    <investigator_full_name>Martin BRUTSCHE</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Demonstrate that DEFA4 is a reliable biomarker for the prediction of adrenal insufficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Adrenal Insufficiency</mesh_term>
  </condition_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/NCT01703013
org study id: KSSG-Pneumo-0001
nct id: NCT01703013
lead sponsor: 
has dmc: No
The pathophysiology of the adrenal insufficiency of patients with critical diseases remains
      unclear. In a prior exploratory study investigating patients with exacerbation of chronic
      obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant
      correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the
      adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to
      demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level
      (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in
      inflammatory lung diseases (patients with COPD and pneumonia).
observational model: Cohort
time perspective: Prospective
Blood leukocytes, serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cantonal Hospital of St. Gallen
investigator full name: Martin BRUTSCHE
investigator title: Prof.
mesh term: Lung Diseases
mesh term: Adrenal Insufficiency