<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF73257-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of Patients with Chronic Obstructive Pulmonary Disease</titl>
      <IDNo>FRESH-PEF73257-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="KAPPA SANTE" role="">Stéphane SCHUCK</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of Patients with Chronic Obstructive Pulmonary Disease            </titl>
      <altTitl>
                    EXACO                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73257-en            </IDNo>
      <IDNo agency="PEF">
                    73257                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73257                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Frédéric MASURE                                                                                </AuthEnty>
      <AuthEnty affiliation="CAB GASTROENTEROLOGIE PUCHELLE CARTERET">
        <ExtLink title="SIREN" URI="347921793" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Alexis CORTOT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)">
        <ExtLink title="ROR" URI="https://ror.org/02ppyfa04" role="organisation id"/>
        <ExtLink title="SIREN" URI="265906719" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Stéphane SCHUCK                                                                                </AuthEnty>
      <AuthEnty affiliation="KAPPA SANTE">
        <ExtLink title="SIREN" URI="445405046" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            SOCIETE DE PNEUMOLOGIE DE LANGUE FRANCAISE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ALTANA PHARMA AG                    
                                    </fundAg>
      <fundAg>
                                            ASTRAZENECA (FRANCE)                    
                                    </fundAg>
      <fundAg>
                                            BOEHRINGER INGELHEIM INTERNATIONAL GMBH                    
                                    </fundAg>
      <fundAg>
                                            GLAXOSMITHKLINE (FRANCE)                    
                                    </fundAg>
      <fundAg>
                                            PFIZER (FRANCE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CAB GASTROENTEROLOGIE PUCHELLE CARTERET" email="fredmasure@gmail.com">
                    Frédéric;MASURE
                                            <ExtLink title="SIREN" URI="347921793" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)" email="alexis.cortot@chru-lille.fr">
                    Alexis;CORTOT
                                            <ExtLink title="ROR" URI="https://ror.org/02ppyfa04" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="265906719" role="organisation id"/>
                                    </contact>
      <contact affiliation="KAPPA SANTE" email="stephane.schuck@kappasante.com">
                    Stéphane;SCHUCK
                                            <ExtLink title="SIREN" URI="445405046" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    bronchitis</keyword>
      <keyword vocab="" vocabURI="">
                    COPD</keyword>
      <keyword vocab="" vocabURI="">
                    exacerbation</keyword>
      <keyword vocab="" vocabURI="">
                    cohort</keyword>
      <topcClas vocab="health theme">
                        Pulmonary medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/f6e18c52-6087-4662-904c-5c4b8174e40e"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D015272"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Chronic obstructive pulmonary disease                                            </topcClas>
    </subject>
    <abstract contentType="purpose">The main aims of the study are to qualitatively and quantitatively describe the exacerbations in a cohort of COPD patients at different levels of severity and to confirm the existence of a sub-group of patients defined as frequent exacerbators who experience a high number of exacerbations over time. Where applicable, to determine the threshold value (number of exacerbations) that distinguishes frequent exacerbations by assuming that 3 exacerbations per year, regardless of severity, are sufficient to class the patient as a “frequent” exacerbator. Several secondary aims will also be pursued. To identify factors associated with frequent exacerbators. To identify criteria more readily associated with exacerbation severity. To confirm the link between frequent exacerbators/accelerated decline in lung function. A validation of the VSRQ scale will be performed with the following metrics: replication; clinical validity through comparison with the St. George questionnaire; VSRQ unidimensional structure; VSRQ internal consistency; sensitivity to change; minimal important distance.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2006-01-01"/>
      <collDate event="end" date="2010-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Respiratory physicians (private practice or hospital: CHG, CHU) will enrol patients aged 40 and over with stage II or III COPD according to SPLF criteria (2003); smokers or ex-smokers (&gt;15 pack-years); stable and with post-bronchodilator FEV1 lower than or equal to 80% of predicted value and FEV1/VC relationship &lt;70%. Patients must accept and complete the self-monitoring log on a monthly basis and, at each exacerbation, can be contacted by phone every three months for 4 years. Participants shall sign a consent form.  The following may not be included: patients with active tuberculosis, cancer (or who received cancer treatment in the last 3 years), diffuse bronchiectasis, cystic fibrosis, asthma (in clinical history), or any other diagnosed lung diseases (sarcoidosis, pulmonary fibrosis, pneumoconiosis, etc.). Other                     </universe>
      <universe clusion="E">Exclusion criteria include exacerbation one month prior to enrolment; absence of a telephone and participation in another clinical or epidemiological study.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>835</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
