Hypersensitivity Pneumonitis of Domestic Origin

NCT05704218 | Not Yet Recruiting

• 1 other identifier: 2022/736
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sensitisation; Mold or Dust Allergy; Respiratory Disease

Keywords

hypersensitivity pneumonitis; molds; dwellings; thresholds

Outcome Measures

Primary Outcomes (3)

• measurement of mold sensitisation

  serology

  2 years

• measurement of mold presence in dwellings

  dust collectors

  2 years

• testing of new fungal antigens

  ELISA

  2 years

Study Arms (1)

domestic HP

OTHER

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

Biological: blood sample

Interventions

blood sample BIOLOGICAL

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

domestic HP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• exposure to mold at home
• given consent
• suspicion of doemstic HP
• clinical signs of interstial pneumopathy

You may not qualify if:

• immunocompromised patients
• prior diagnosis of another HP form (avian, farm, bath tub etc..)
• exposure to avian proteins

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Respiration Disorders; Alveolitis, Extrinsic Allergic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Anne-Pauline BELLANGER

CONTACT

0370632351; apbellanger@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 30, 2023
• Study Start: February 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 30, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share