xml: <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/NCT05988437</url>
    </required_header>
    <id_info>
      <org_study_id>RC23_0282</org_study_id>
      <nct_id>NCT05988437</nct_id>
    </id_info>
    <brief_title>Contribution of the Indoor Environment Medical Advisor in the Management of Chronic Hypersensitivity Pneumonitis</brief_title>
    <acronym>PHSaDom</acronym>
    <official_title>Contribution of the Indoor Environment Medical Advisor in the Management of Chronic Hypersensitivity Pneumonitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nantes University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nantes University Hospital</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>
        Hypersensitivity pneumonitis (HP) is a diffuse infiltrative pneumonitis (DIP) of&#xD;
        immuno-allergic origin, caused by exposure to one or more antigenic substances of organic&#xD;
        origin, in genetically predisposed individuals. It can take a fibrosing form, eventually&#xD;
        leading to chronic respiratory failure. Diagnosis is based on a combination of clinical,&#xD;
        biological, CT scan and histological evidence, and is made during multidisciplinary&#xD;
        discussions (MDD) of diffuse interstitial lung disease.&#xD;
  &#xD;
        The antigens responsible, of domestic or professional origin, may be micro-organisms, animal&#xD;
        proteins or chemical agents. However, the antigen remains unknown in almost 50% of cases.&#xD;
        Lack of antigen identification is an independent risk factor for death in patients with&#xD;
        fibrosing HP. In fibrosing forms, corticosteroid therapy does not appear to improve&#xD;
        functional prognosis, and ninedanib, an antifibrosing treatment offered in progressive forms,&#xD;
        only slows functional decline. Identifying the causative antigen is therefore an essential&#xD;
        element in the overall management of these patients, with the aim of implementing avoidance&#xD;
        measures. A medical exposure questionnaire has been translated into French to help physicians&#xD;
        identify the antigen.&#xD;
  &#xD;
        The serum precipitin assay is a tool developed to help identify sensitization to an antigen.&#xD;
        It is all the more useful when investigations are targeted at the patient's suspected&#xD;
        exposure. However, their sensitivity and specificity are variable.&#xD;
  &#xD;
        The activity of the indoor environment medical advisor (CMEI) has developed in the care of&#xD;
        patients with chronic respiratory or allergic pathologies. Their role is to carry out an&#xD;
        audit of the dwelling, take environmental measurements to assess the health risk, inform&#xD;
        patients about appropriate eviction measures and, in some cases, refer patients to&#xD;
        organizations specializing in home improvement.&#xD;
  &#xD;
        The CMEI visits the patient's home. The environmental audit includes a rigorous macroscopic&#xD;
        examination and microbiological swabs of visible anomalies. The CMEI can also supplement its&#xD;
        analysis with electrostatic dust collectors, which are left in the home for 4 weeks, enabling&#xD;
        both qualitative and quantitative characterization of antigens.&#xD;
  &#xD;
        To date, no study has prospectively evaluated the contribution of CMEI to antigen&#xD;
        identification in patients with fibrosing HP. At the Nantes University Hospital and Angers&#xD;
        University Hospital, the environmental audit carried out by the CMEI is an integral part of&#xD;
        routine patient management in the event of a HP diagnosis.&#xD;
  &#xD;
        The main objective of this study is to measure the diagnostic contribution of the indoor&#xD;
        environment medical advisor in the identification of antigens responsible for respiratory&#xD;
        pathology in patients with fibrosing HP.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be prospectively recruited as incidental cases during multidisciplinary&#xD;
        discussions of diffuse interstitial lung disease organized on a regular monthly basis between&#xD;
        university hospitals, private lung specialists and those practising in outlying hospitals.&#xD;
  &#xD;
        Once the patient's non-objection has been collected, a medical self-exposure questionnaire&#xD;
        will be completed, and the antigens identified by the questionnaire will be listed (time T1).&#xD;
  &#xD;
        As in current practice, the indoor environment medical advisor (CMEI) will then visit the&#xD;
        patient's home to carry out an environmental audit, including a macroscopic assessment and&#xD;
        swabbing for any abnormalities that might suggest risky antigenic exposure. The results of&#xD;
        the swab analysis will be collected along with a number of antigens (T2 time). During this&#xD;
        visit, a sensor will be placed in the patient's home for a period of 4 weeks, and the results&#xD;
        will be collected after 4 weeks in the home with a number of antigens (time T3).&#xD;
  &#xD;
        Following these 3 evaluation times, serum precipitins will be collected according to the&#xD;
        antigens identified during the 3 visits.&#xD;
  &#xD;
        As part of the patient follow-up, a telephone call by the CMEI at 6 months from the initial&#xD;
        environmental audit will assess whether eviction of the identified antigens has been&#xD;
        effective. Similarly, at 12 months, the CMEI will make another home visit to assess the rate&#xD;
        of eviction of the antigens identified at the initial visit.&#xD;
  &#xD;
        In parallel, as part of routine care, a clinical and functional evaluation will be carried&#xD;
        out at diagnosis, 6 months and 12 months. A radiological assessment involving a chest CT scan&#xD;
        will be performed at diagnosis and at 12 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 12, 2023</start_date>
    <completion_date type="Anticipated">June 12, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 12, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To measure the diagnostic contribution of the indoor environment medical advisor in the identification of antigens responsible for respiratory pathology in patients with fibrosing hypersensitivity pneumonitis</measure>
      <time_frame>1 month</time_frame>
      <description>Difference in the number of hypersensitivity pneumonitis (HP) risk antigens identified on the one hand by the medical exposure questionnaire and on the other by the indoor environment medical consultant in subjects with HP.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measure the diagnostic contribution of electrostatic dust sensors in the identification of antigens in patients with fibrosing hypersensitivity pneumonitis</measure>
      <time_frame>12 month</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantify the number of antigens identified using the medical exposure questionnaire, the number of antigens identified by the environment medical advisor, and the number of antigens identified using electrostatic sensors</measure>
      <time_frame>1 month</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measure the positivity rate of serum precipitins collected in a manner appropriate to the exposures found</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measure the application of eviction advice and the rate of eviction of previously identified antigens 6 months and 12 months after the visit of the environment medical advisor</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the clinical evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the clinical evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the functional evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the functional evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the scanographic evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the scanographic evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hypersensitivity Pneumonitis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients will be prospectively recruited as incidental cases during multidisciplinary&#xD;
          discussions of diffuse interstitial lung disease (Diffuse Interstitial Lung Disease)&#xD;
          organized on a regular monthly basis between hospital-university centers, private lung&#xD;
          specialists and those practising in outlying hospitals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient of legal age,&#xD;
  &#xD;
            -  French-speaking patient,&#xD;
  &#xD;
            -  Patient with a diagnosis of fibrosing PHS following a multidisciplinary discussion of&#xD;
               diffuse interstitial lung disease hypersensitivity pneumonitis .&#xD;
  &#xD;
            -  Patient who had received an information note presenting the study and who had not&#xD;
               expressed opposition to participating in this research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Opposition of the patient to participate in the study,&#xD;
  &#xD;
            -  Patient under guardianship, curatorship or safeguard of justice,&#xD;
  &#xD;
            -  Patients who have moved within the last 12 months, or who plan to move within the next&#xD;
               6 months,&#xD;
  &#xD;
            -  Patients who have already had a visit from the indoor environment medical advisor.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Stéphanie DIROU, PH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nantes University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stéphanie DIROU, PH</last_name>
      <phone>+33 2 53 48 27 74</phone>
      <email>stéphanie.dirou@chu-nantes.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>François Xavier BLANC, PU PH</last_name>
      <phone>+33 2 40 16 52 36</phone>
      <email>xavier.blanc@chu-nantes.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU de Nantes</name>
        <address>
          <city>Nantes</city>
          <state>Loire-Atlantique</state>
          <zip>44093</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Stéphanie DIROU, PH</last_name>
        <email>stéphanie.dirou@chu-nantes.fr</email>
      </contact>
      <investigator>
        <last_name>Stéphanie DIROU</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>François Xavier BLANC</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Charlotte MENIGOZ</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fibrosing</keyword>
    <keyword>indoor environment medical advisor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</mesh_term>
      <mesh_term>Alveolitis, Extrinsic Allergic</mesh_term>
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988437
  org study id: RC23_0282
  nct id: NCT05988437
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hypersensitivity pneumonitis (HP) is a diffuse infiltrative pneumonitis (DIP) of
        immuno-allergic origin, caused by exposure to one or more antigenic substances of organic
        origin, in genetically predisposed individuals. It can take a fibrosing form, eventually
        leading to chronic respiratory failure. Diagnosis is based on a combination of clinical,
        biological, CT scan and histological evidence, and is made during multidisciplinary
        discussions (MDD) of diffuse interstitial lung disease.
  
        The antigens responsible, of domestic or professional origin, may be micro-organisms, animal
        proteins or chemical agents. However, the antigen remains unknown in almost 50% of cases.
        Lack of antigen identification is an independent risk factor for death in patients with
        fibrosing HP. In fibrosing forms, corticosteroid therapy does not appear to improve
        functional prognosis, and ninedanib, an antifibrosing treatment offered in progressive forms,
        only slows functional decline. Identifying the causative antigen is therefore an essential
        element in the overall management of these patients, with the aim of implementing avoidance
        measures. A medical exposure questionnaire has been translated into French to help physicians
        identify the antigen.
  
        The serum precipitin assay is a tool developed to help identify sensitization to an antigen.
        It is all the more useful when investigations are targeted at the patient's suspected
        exposure. However, their sensitivity and specificity are variable.
  
        The activity of the indoor environment medical advisor (CMEI) has developed in the care of
        patients with chronic respiratory or allergic pathologies. Their role is to carry out an
        audit of the dwelling, take environmental measurements to assess the health risk, inform
        patients about appropriate eviction measures and, in some cases, refer patients to
        organizations specializing in home improvement.
  
        The CMEI visits the patient's home. The environmental audit includes a rigorous macroscopic
        examination and microbiological swabs of visible anomalies. The CMEI can also supplement its
        analysis with electrostatic dust collectors, which are left in the home for 4 weeks, enabling
        both qualitative and quantitative characterization of antigens.
  
        To date, no study has prospectively evaluated the contribution of CMEI to antigen
        identification in patients with fibrosing HP. At the Nantes University Hospital and Angers
        University Hospital, the environmental audit carried out by the CMEI is an integral part of
        routine patient management in the event of a HP diagnosis.
  
        The main objective of this study is to measure the diagnostic contribution of the indoor
        environment medical advisor in the identification of antigens responsible for respiratory
        pathology in patients with fibrosing HP.
  Patients will be prospectively recruited as incidental cases during multidisciplinary
        discussions of diffuse interstitial lung disease organized on a regular monthly basis between
        university hospitals, private lung specialists and those practising in outlying hospitals.
  
        Once the patient's non-objection has been collected, a medical self-exposure questionnaire
        will be completed, and the antigens identified by the questionnaire will be listed (time T1).
  
        As in current practice, the indoor environment medical advisor (CMEI) will then visit the
        patient's home to carry out an environmental audit, including a macroscopic assessment and
        swabbing for any abnormalities that might suggest risky antigenic exposure. The results of
        the swab analysis will be collected along with a number of antigens (T2 time). During this
        visit, a sensor will be placed in the patient's home for a period of 4 weeks, and the results
        will be collected after 4 weeks in the home with a number of antigens (time T3).
  
        Following these 3 evaluation times, serum precipitins will be collected according to the
        antigens identified during the 3 visits.
  
        As part of the patient follow-up, a telephone call by the CMEI at 6 months from the initial
        environmental audit will assess whether eviction of the identified antigens has been
        effective. Similarly, at 12 months, the CMEI will make another home visit to assess the rate
        of eviction of the antigens identified at the initial visit.
  
        In parallel, as part of routine care, a clinical and functional evaluation will be carried
        out at diagnosis, 6 months and 12 months. A radiological assessment involving a chest CT scan
        will be performed at diagnosis and at 12 months.
  observational model: Case-Only
  time perspective: Prospective
  measure: To measure the diagnostic contribution of the indoor environment medical advisor in the identification of antigens responsible for respiratory pathology in patients with fibrosing hypersensitivity pneumonitis
  time frame: 1 month
  description: Difference in the number of hypersensitivity pneumonitis (HP) risk antigens identified on the one hand by the medical exposure questionnaire and on the other by the indoor environment medical consultant in subjects with HP.
  measure: Measure the diagnostic contribution of electrostatic dust sensors in the identification of antigens in patients with fibrosing hypersensitivity pneumonitis
  time frame: 12 month
  measure: Quantify the number of antigens identified using the medical exposure questionnaire, the number of antigens identified by the environment medical advisor, and the number of antigens identified using electrostatic sensors
  time frame: 1 month
  measure: Measure the positivity rate of serum precipitins collected in a manner appropriate to the exposures found
  time frame: 6 months
  measure: Measure the application of eviction advice and the rate of eviction of previously identified antigens 6 months and 12 months after the visit of the environment medical advisor
  time frame: 12 months
  measure: Evaluate the clinical evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
  time frame: 6 months
  measure: Evaluate the clinical evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
  time frame: 12 months
  measure: Evaluate the functional evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
  time frame: 6 months
  measure: Evaluate the functional evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
  time frame: 12 months
  measure: Evaluate the scanographic evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
  time frame: 6 months
  measure: Evaluate the scanographic evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
  time frame: 12 months
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Stéphanie DIROU, PH
  role: Principal Investigator
  affiliation: Nantes University Hospital
  last name: Stéphanie DIROU, PH
  phone: +33 2 53 48 27 74
  email: stéphanie.dirou@chu-nantes.fr
  last name: François Xavier BLANC, PU PH
  phone: +33 2 40 16 52 36
  email: xavier.blanc@chu-nantes.fr
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Pneumonia
  mesh term: Alveolitis, Extrinsic Allergic
  mesh term: Hypersensitivity