Clinical trial NCT05704218: Hypersensitivity Pneumonitis of Domestic Origin
Official title: Hypersensitivity Pneumonitis of Domestic Origin: Investigation of the Microorganisms Involved and Improvement of Serological Diagnosis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sensitisation
Mold or Dust Allergy
Respiratory Disease
Keywords: hypersensitivity pneumonitis
molds
dwellings
thresholds
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: measurement of mold sensitisation
timeFrame: 2 years
measure: measurement of mold presence in dwellings
timeFrame: 2 years
measure: testing of new fungal antigens
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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