<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/NCT02186639</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2014-0088</org_study_id>
    <nct_id>NCT02186639</nct_id>
  </id_info>
  <brief_title>Breath Analysis in Chronic Obstructive Lung Disease (COPD)</brief_title>
  <official_title>Exhaled Breath Analysis in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To answer the question whether a disease specific profile of breath in patients with COPD can&#xD;
      be detected by an untargeted metabolomic study using exhaled breath analysis by mass&#xD;
      spectrometry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study comparing the volatile organic compounds (VOCs) in exhaled&#xD;
      breath between COPD patients and matched control subjects (age, gender, smoking-state). 40&#xD;
      COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be&#xD;
      examined by SESI-MS on the composition of exhaled breath for identification of COPD specific&#xD;
      markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">December 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>COPD-specific mass spectrometric exhaled breath pattern</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>40 COPD patients (20 non-frequent and 20 frequent-exacerbators). No intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Subjects with no apparent lung disease and normal lung function testing. Matched for age, gender and smoking history (pack years).&#xD;
No intervention.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited in primary, secondary and tertiary care clinics. Healthy&#xD;
        controls will be recruited from a community sample.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC &lt;&#xD;
             0.7) performed within the last 6 months&#xD;
&#xD;
          -  age between 18 and 80 years at study entry&#xD;
&#xD;
          -  healthy controls: normal spirometry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COPD exacerbation within the last 6 weeks&#xD;
&#xD;
          -  any lung disease other than COPD&#xD;
&#xD;
          -  acute inflammatory disease (e.g. common cold) within the last 6 weeks&#xD;
&#xD;
          -  acute or chronic hepatic disease&#xD;
&#xD;
          -  renal failure or renal replacement therapy&#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>
  <overall_official>
    <last_name>Malcolm Kohler, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Pulmonary Division</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Pulmonary Division</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 27, 2018</last_update_submitted>
  <last_update_submitted_qc>March 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exhaled breath</keyword>
  <keyword>volatile organic compounds (VOCs)</keyword>
  <keyword>SESI-MS</keyword>
  <!-- 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/NCT02186639
org study id: KEK-ZH-Nr. 2014-0088
nct id: NCT02186639
lead sponsor: 
collaborator: 
has dmc: No
To answer the question whether a disease specific profile of breath in patients with COPD can
      be detected by an untargeted metabolomic study using exhaled breath analysis by mass
      spectrometry.
This is an observational study comparing the volatile organic compounds (VOCs) in exhaled
      breath between COPD patients and matched control subjects (age, gender, smoking-state). 40
      COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be
      examined by SESI-MS on the composition of exhaled breath for identification of COPD specific
      markers.
observational model: Case-Control
time perspective: Prospective
measure: COPD-specific mass spectrometric exhaled breath pattern
time frame: baseline
arm group label: COPD
description: 40 COPD patients (20 non-frequent and 20 frequent-exacerbators). No intervention.
arm group label: Controls
description: Subjects with no apparent lung disease and normal lung function testing. Matched for age, gender and smoking history (pack years).
No intervention.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Malcolm Kohler, Prof.
role: Principal Investigator
affiliation: University Hospital Zurich, Pulmonary Division
facility: 
country: Switzerland
responsible party type: Sponsor