Hypersensitivity Pneumonitis of Domestic Origin

NCT ID: NCT05704218

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Sensitisation Mold or Dust Allergy Respiratory Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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domestic HP

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

Group Type OTHER

blood sample

Intervention Type BIOLOGICAL

the patient will have a blood sample in order to perform serology tests

Interventions

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blood sample

the patient will have a blood sample in order to perform serology tests

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Anne-Pauline BELLANGER

Role: CONTACT

0370632351

Other Identifiers

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2022/736

Identifier Type: -

Identifier Source: org_study_id

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