Hypersensitivity Pneumonitis of Domestic Origin

Not Applicable

Not yet recruiting

• Conditions: Sensitisation; Mold or Dust Allergy; Respiratory Disease
• Interventions: Biological: blood sample

• Registration Number: NCT05704218
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-30
• Study Start: 2023-02
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
domestic HP	blood sample	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

Primary Outcome Measures

Name	Time	Method
measurement of mold sensitisation	2 years	serology
measurement of mold presence in dwellings	2 years	dust collectors
testing of new fungal antigens	2 years	ELISA