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
About this trial
This is an interventional diagnostic trial for Sensitisation focused on measuring hypersensitivity pneumonitis, molds, dwellings, thresholds
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
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
NCT ID
NCT05704218
First Posted
December 2, 2022
Last Updated
January 19, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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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