<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/NCT02264483</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-EPO-2013-152</org_study_id>
    <nct_id>NCT02264483</nct_id>
  </id_info>
  <brief_title>Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.</brief_title>
  <official_title>Assessment of the Degree of Pneumonia Underdiagnosis in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Using Chest Low-dose Computed Tomography (CT) and Comparison of Inflammatory Profile Between the Two Entities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sociedad Española de Neumología y Cirugía Torácica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      * Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary&#xD;
      Disease) exacerbations which could be demonstrated by performing low-dose chest CT.&#xD;
      Differences in the inflammatory profile in sputum and blood in patients with and without&#xD;
      pneumonia can be seen.&#xD;
&#xD;
      * Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using&#xD;
      chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum&#xD;
      between patients with and without pneumonia.&#xD;
&#xD;
      *Material and Methods: Prospective observational study including 75 patients with the&#xD;
      diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract&#xD;
      infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray&#xD;
      and chest low-dose CT are performed. The investigators divide the patients into two groups&#xD;
      according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory&#xD;
      markers) and sputum (cell populations and inflammatory markers) is compared between the two&#xD;
      branches.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with an exacerbation of their disease who have a Pneumonia diagnosed by low dose - CT (not detected by chest X-Ray).</measure>
    <time_frame>1 year and a half</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>COPD exacerbation</arm_group_label>
    <description>No intervention.&#xD;
The subjects will be divided in 2 subgroups according to the image study:&#xD;
COPD exacerbation with pneumonia&#xD;
COPD exacerbation without pneumonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD stable patients</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples and sputum (supernatant)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients with an exacerbation of their disease and symptoms of respiratory infection,&#xD;
        wich come to visit at outpatient pneumologic clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  clinical and spirometric diagnosis of COPD.&#xD;
&#xD;
          -  for study group: clinical symptoms of exacerbation and infection of low airway.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  No acceptance of informed consent.&#xD;
&#xD;
          -  The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation.&#xD;
&#xD;
          -  Another entity known pulmonology other than COPD (non-obstructive disorders,&#xD;
             bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension,&#xD;
             hypoventilation).&#xD;
&#xD;
          -  Chronic treatment with oral corticosteroids or immunosuppressive drug.&#xD;
&#xD;
          -  severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary&#xD;
             tuberculosis with important involvement, severe pneumoconiosis.&#xD;
&#xD;
          -  Severe alteration of nutritional status.&#xD;
&#xD;
          -  Heart disease evolved.&#xD;
&#xD;
          -  Limitation for understanding the study (including psychiatric disorder, language&#xD;
             problem, social or cultural differences, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Solanes, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Sebastian</last_name>
    <email>lsebastian@santpau.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastian</last_name>
      <email>lsebastian@santpau.cat</email>
    </contact>
    <investigator>
      <last_name>Laura Sebastian, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tomas Franquet, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ana M Giménez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>August 28, 2015</last_update_submitted>
  <last_update_submitted_qc>August 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pneumonia in COPD exacerbation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02264483
org study id: IIBSP-EPO-2013-152
nct id: NCT02264483
lead sponsor: 
collaborator: 
has dmc: No
* Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary
      Disease) exacerbations which could be demonstrated by performing low-dose chest CT.
      Differences in the inflammatory profile in sputum and blood in patients with and without
      pneumonia can be seen.

      * Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using
      chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum
      between patients with and without pneumonia.

      *Material and Methods: Prospective observational study including 75 patients with the
      diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract
      infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray
      and chest low-dose CT are performed. The investigators divide the patients into two groups
      according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory
      markers) and sputum (cell populations and inflammatory markers) is compared between the two
      branches.
observational model: Case-Control
time perspective: Prospective
measure: Number of patients with an exacerbation of their disease who have a Pneumonia diagnosed by low dose - CT (not detected by chest X-Ray).
time frame: 1 year and a half
arm group label: COPD exacerbation
description: No intervention.
The subjects will be divided in 2 subgroups according to the image study:
COPD exacerbation with pneumonia
COPD exacerbation without pneumonia
arm group label: COPD stable patients
Blood samples and sputum (supernatant)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ingrid Solanes, MD PhD
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
last name: Laura Sebastian
email: lsebastian@santpau.cat
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pulmonary Disease, Chronic Obstructive