Hypersensitivity Pneumonitis of Domestic Origin

Respiratory Disease Clinical Trial

— HOME-HP  

Official title:

Hypersensitivity Pneumonitis of Domestic Origin: Investigation of the Microorganisms Involved and Improvement of Serological Diagnosis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05704218
• Other study ID #: 2022/736
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: March 2026

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Anne-Pauline BELLANGER
• Phone: 0370632351
• Email: apbellanger[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Hypersensitivity
• Pneumonia
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Sensitisation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of mold sensitisation	serology	2 years
Primary	measurement of mold presence in dwellings	dust collectors	2 years
Primary	testing of new fungal antigens	ELISA	2 years