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Hypersensitivity Pneumonitis of Domestic Origin (HOME-HP)

Primary Purpose

Sensitisation, Mold or Dust Allergy, Respiratory Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood sample
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sensitisation focused on measuring hypersensitivity pneumonitis, molds, dwellings, thresholds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: exposure to mold at home given consent suspicion of doemstic HP clinical signs of interstial pneumopathy Exclusion Criteria: immunocompromised patients prior diagnosis of another HP form (avian, farm, bath tub etc..) exposure to avian proteins

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    domestic HP

    Arm Description

    All the patients will be in the same arm until obtention of the final diagnosis. The final diagnosis will be used to compare data of serology to determine thresholds

    Outcomes

    Primary Outcome Measures

    measurement of mold sensitisation
    serology
    measurement of mold presence in dwellings
    dust collectors
    testing of new fungal antigens
    ELISA

    Secondary Outcome Measures

    Full Information

    First Posted
    December 2, 2022
    Last Updated
    January 19, 2023
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05704218
    Brief Title
    Hypersensitivity Pneumonitis of Domestic Origin
    Acronym
    HOME-HP
    Official Title
    Hypersensitivity Pneumonitis of Domestic Origin: Investigation of the Microorganisms Involved and Improvement of Serological Diagnosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    March 2026 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Exposure to molds in dwellings is a public health problem. Diagnosis of hypersensitivity pneumonitis due to mold exposure at home (domestic HP) are increasing. To perform the serodiagnosis of domestic HP a cohort constitued of proven cases and exposed healthy controls are needed. The HOME HP study aimed at obtaining a cohort of proven cases and exposed controls in order to be able to improve the serodiagnosis of domestic HP.
    Detailed Description
    Hypersensitivy pneumonitis (HP) are chronic respiratory diseases due to frequent exposure to high quantities of allergens (molds, bacteria, mycobacteria, avian proteins). In case of domestic HP, patients are exposed at home to molds due to flooding or poor ventilation. The diagnosis of domestic HP includes detection of IgG towards molds. A prior study in 2005 allowed the determination of frequent allergenic molds isolated in homes in Bourgogne Franche Comte (study on 110 dwellings). However, no real cohort of proven cases versus controls is available. So, we are lacking validated thresholds. The HOME HP study is a prospective study that will include several centers of pneumology on France territory. The fungal contamination of dwellings occupied by patients suffering of interstitial disease (DIP), including suspicion of domestic HP, will be analyzed. The most frequently isolated molds will be then produced as antigens and will be tested in order to assess the sensitization of the included patients. The data of imagery, BALF cytology will allow to determine if patients are diagnosed with domestic HP or not. We will then obtain 2 groups of patients 1-proven domestic HP and 2-non domestic HP . Comparing the number of immunization arcs between the 2 groups will then be possible to validate appropriate thresholds for the serodiagnosis of domestic HP. Domestic HP are rare diseases, so a high number of inclusions will be needed to obatin in 2 years about 25-30 proven cases. The HOME HP study is important to improve the serodiagnosis of domestic HP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sensitisation, Mold or Dust Allergy, Respiratory Disease
    Keywords
    hypersensitivity pneumonitis, molds, dwellings, thresholds

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    the final diagnosis will be judged by the pneumologist on plural results: imagery, BALF cytology. The final diagnosis will be used to make 2 groups proven / non proven domestic forms
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    domestic HP
    Arm Type
    Other
    Arm Description
    All the patients will be in the same arm until obtention of the final diagnosis. The final diagnosis will be used to compare data of serology to determine thresholds
    Intervention Type
    Biological
    Intervention Name(s)
    blood sample
    Intervention Description
    the patient will have a blood sample in order to perform serology tests
    Primary Outcome Measure Information:
    Title
    measurement of mold sensitisation
    Description
    serology
    Time Frame
    2 years
    Title
    measurement of mold presence in dwellings
    Description
    dust collectors
    Time Frame
    2 years
    Title
    testing of new fungal antigens
    Description
    ELISA
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: exposure to mold at home given consent suspicion of doemstic HP clinical signs of interstial pneumopathy Exclusion Criteria: immunocompromised patients prior diagnosis of another HP form (avian, farm, bath tub etc..) exposure to avian proteins
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne-Pauline BELLANGER
    Phone
    0370632351
    Email
    apbellanger@chu-besancon.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hypersensitivity Pneumonitis of Domestic Origin

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