<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/NCT01713335</url>
  </required_header>
  <id_info>
    <org_study_id>C11-56</org_study_id>
    <secondary_id>2012-A00885-38</secondary_id>
    <nct_id>NCT01713335</nct_id>
  </id_info>
  <brief_title>Proteasis Evaluation in COPD</brief_title>
  <acronym>Pro-BPCO</acronym>
  <official_title>Proteasis Evaluation in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients.&#xD;
      Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide&#xD;
      bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess&#xD;
      Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be&#xD;
      included: Healthy smoker subjects, stable COPD patients and COPD patients with acute&#xD;
      exacerbation. Kallicrein levels in sputum will be compared in these groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kallikrein level in sputum by ELISA</measure>
    <time_frame>One sample at inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between kallikrein level and clinical or functionnal parameters</measure>
    <time_frame>All data will be identified at inclusion</time_frame>
    <description>Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score</description>
  </secondary_outcome>
  <enrollment type="Actual">134</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Stable COPD patients were recruited from pulmonary primary care of pulmonary division of&#xD;
        CHRU of Tours.&#xD;
&#xD;
        COPD with acute exacerbation were recruited from hospitalisation of pulmonary division of&#xD;
        CHRU of Tours and intensive care unit of CHRU of Tours.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for healthy subjects:&#xD;
&#xD;
          -  Smoker with tobacco consumption of 20 pack/year&#xD;
&#xD;
          -  Normal lung function tests&#xD;
&#xD;
        Exclusion Criteria for healthy subjects:&#xD;
&#xD;
          -  diagnosis of lung disease during the study&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Lung cancer&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
        Inclusion Criteria for stable COPD:&#xD;
&#xD;
          -  Smoker with tobacco consumption of 20 pack/year&#xD;
&#xD;
          -  FEV1/FVC&lt;70% on lung function tests&#xD;
&#xD;
          -  no hospitalisation for exacerbation during 3 months before inclusion&#xD;
&#xD;
        Exclusion Criteria for stable COPD:&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Lung cancer&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
        Inclusion Criteria for COPD with exacerbation:&#xD;
&#xD;
          -  Smoker with tobacco consumption of 20 pack/year&#xD;
&#xD;
          -  worsening of pulmonary symptoms&#xD;
&#xD;
          -  FEV1/FVC&lt;70% on lung function tests could be obtain before or 3 months after&#xD;
             exacerbation&#xD;
&#xD;
        Exclusion Criteria for COPD with exacerbation:&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Lung cancer&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurent Guilleminault, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Pneumologie, CHRU Tours, Tours, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valérie Gissot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre d'Investigation Clinique, CHRU Tours, Tours, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoine Guillon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Réanimation médicale, CHRU Tours, Tours, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</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/NCT01713335
org study id: C11-56
secondary id: 2012-A00885-38
nct id: NCT01713335
lead sponsor: 
has dmc: No
The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients.
      Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide
      bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess
      Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be
      included: Healthy smoker subjects, stable COPD patients and COPD patients with acute
      exacerbation. Kallicrein levels in sputum will be compared in these groups.
observational model: Other
time perspective: Prospective
measure: Kallikrein level in sputum by ELISA
time frame: One sample at inclusion
measure: Comparison between kallikrein level and clinical or functionnal parameters
time frame: All data will be identified at inclusion
description: Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score
Sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laurent Guilleminault, MD
role: Principal Investigator
affiliation: Service de Pneumologie, CHRU Tours, Tours, France
last name: Valérie Gissot, MD
role: Principal Investigator
affiliation: Centre d'Investigation Clinique, CHRU Tours, Tours, France
last name: Antoine Guillon, MD
role: Principal Investigator
affiliation: Service de Réanimation médicale, CHRU Tours, Tours, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive