<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/NCT03299907</url>
  </required_header>
  <id_info>
    <org_study_id>P/2013/161</org_study_id>
    <nct_id>NCT03299907</nct_id>
  </id_info>
  <brief_title>COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)</brief_title>
  <acronym>BM3R</acronym>
  <official_title>COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BPCO MSA 3Régions : épidémiologie et Facteurs de Risque de la BPCO en Milieu Rural)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mutualité sociale agricole</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The agricultural environment presents a unique profile in terms of epidemiology of pulmonary&#xD;
      diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD&#xD;
      is higher in farmers than in the general population, despite less smoking. It is likely that&#xD;
      the risk of COPD depends on several factors, such as the type of farm, local conditions and&#xD;
      the region where the farm is located. It is important to diagnose COPD at an early stage in&#xD;
      order to initiate appropriate therapy, and implement secondary prevention with a view to&#xD;
      limiting deterioration of respiratory function and reducing complications. In this context,&#xD;
      the aims of BM3R project were: (1) to study the epidemiology of COPD in a large&#xD;
      representative sample of French farmers, in order to identify the types of farming, working&#xD;
      conditions and regions that are associated with the presence of COPD; and (2) to develop a&#xD;
      score to identify patients at risk and optimise diagnosis of COPD in the context of a&#xD;
      screening programme.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2012</start_date>
  <completion_date type="Actual">May 30, 2014</completion_date>
  <primary_completion_date type="Actual">May 30, 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>FEV1/FVC</measure>
    <time_frame>At the inclusion time</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5263</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>Subject with FEV1/FVC post BD &lt; 0.7 or LLN</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non COPD</arm_group_label>
    <description>Subject with FEV1/FVC post BD &gt;= 0.7 or LLN</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Spirometry</intervention_name>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_label>Non COPD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data were collected between October 2012 and May 2013 in two French regions (Brittany and&#xD;
        Franche-Comté) among affiliated members (farmers and administrative workers of both sexes)&#xD;
        of the MSA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 40 years old and &lt; 75 years old&#xD;
&#xD;
          -  Affiliated to the MSA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COPD known&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno DEGANO, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Besançon</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</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>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/NCT03299907
org study id: P/2013/161
nct id: NCT03299907
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The agricultural environment presents a unique profile in terms of epidemiology of pulmonary
      diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD
      is higher in farmers than in the general population, despite less smoking. It is likely that
      the risk of COPD depends on several factors, such as the type of farm, local conditions and
      the region where the farm is located. It is important to diagnose COPD at an early stage in
      order to initiate appropriate therapy, and implement secondary prevention with a view to
      limiting deterioration of respiratory function and reducing complications. In this context,
      the aims of BM3R project were: (1) to study the epidemiology of COPD in a large
      representative sample of French farmers, in order to identify the types of farming, working
      conditions and regions that are associated with the presence of COPD; and (2) to develop a
      score to identify patients at risk and optimise diagnosis of COPD in the context of a
      screening programme.
observational model: Other
time perspective: Cross-Sectional
measure: FEV1/FVC
time frame: At the inclusion time
arm group label: COPD
description: Subject with FEV1/FVC post BD < 0.7 or LLN
arm group label: Non COPD
description: Subject with FEV1/FVC post BD >= 0.7 or LLN
intervention type: Diagnostic Test
intervention name: Spirometry
arm group label: COPD
arm group label: Non COPD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruno DEGANO, MD
role: Principal Investigator
affiliation: CHU Besançon
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive