Contribution of the Indoor Environment Medical Advisor in the Management of Fibrosing Hypersensitivity Pneumonitis

NCT05988437 | Not Yet Recruiting

• 1 other identifier: RC23_0282
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Hypersensitivity pneumonitis (HP) is a diffuse infiltrative pneumonitis (DIP) of immuno-allergic origin, caused by exposure to one or more antigenic substances of organic origin, in genetically predisposed individuals. It can take a fibrosing form, eventually leading to chronic respiratory failure. Diagnosis is based on a combination of clinical, biological, CT scan and histological evidence, and is made during multidisciplinary discussions (MDD) of diffuse interstitial lung disease. The antigens responsible, of domestic or professional origin, may be micro-organisms, animal proteins or chemical agents. However, the antigen remains unknown in almost 50% of cases. Lack of antigen identification is an independent risk factor for death in patients with fibrosing HP. In fibrosing forms, corticosteroid therapy does not appear to improve functional prognosis, and ninedanib, an antifibrosing treatment offered in progressive forms, only slows functional decline. Identifying the causative antigen is therefore an essential element in the overall management of these patients, with the aim of implementing avoidance measures. A medical exposure questionnaire has been translated into French to help physicians identify the antigen. The serum precipitin assay is a tool developed to help identify sensitization to an antigen. It is all the more useful when investigations are targeted at the patient's suspected exposure. However, their sensitivity and specificity are variable. The activity of the indoor environment medical advisor (CMEI) has developed in the care of patients with chronic respiratory or allergic pathologies. Their role is to carry out an audit of the dwelling, take environmental measurements to assess the health risk, inform patients about appropriate eviction measures and, in some cases, refer patients to organizations specializing in home improvement. The CMEI visits the patient's home. The environmental audit includes a rigorous macroscopic examination and microbiological swabs of visible anomalies. The CMEI can also supplement its analysis with electrostatic dust collectors, which are left in the home for 4 weeks, enabling both qualitative and quantitative characterization of antigens. To date, no study has prospectively evaluated the contribution of CMEI to antigen identification in patients with fibrosing HP. At the Nantes University Hospital and Angers University Hospital, the environmental audit carried out by the CMEI is an integral part of routine patient management in the event of a HP diagnosis. The main objective of this study is to measure the diagnostic contribution of the indoor environment medical advisor in the identification of antigens responsible for respiratory pathology in patients with fibrosing HP.

Conditions

Hypersensitivity Pneumonitis

Keywords

Fibrosing; indoor environment medical advisor

Outcome Measures

Primary Outcomes (1)

• To measure the diagnostic contribution of the indoor environment medical advisor in the identification of antigens responsible for respiratory pathology in patients with fibrosing hypersensitivity pneumonitis

  Difference in the number of hypersensitivity pneumonitis (HP) risk antigens identified on the one hand by the medical exposure questionnaire and on the other by the indoor environment medical consultant in subjects with HP.

  1 month

Secondary Outcomes (10)

• Measure the diagnostic contribution of electrostatic dust sensors in the identification of antigens in patients with fibrosing hypersensitivity pneumonitis

  12 month

• Quantify the number of antigens identified using the medical exposure questionnaire, the number of antigens identified by the environment medical advisor, and the number of antigens identified using electrostatic sensors

  1 month

• Measure the positivity rate of serum precipitins collected in a manner appropriate to the exposures found

  6 months

• Measure the application of eviction advice and the rate of eviction of previously identified antigens 6 months and 12 months after the visit of the environment medical advisor

  12 months

• Evaluate the clinical evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be prospectively recruited as incidental cases during multidisciplinary discussions of diffuse interstitial lung disease (Diffuse Interstitial Lung Disease) organized on a regular monthly basis between hospital-university centers, private lung specialists and those practising in outlying hospitals.

You may qualify if:

• Patient of legal age,
• French-speaking patient,
• Patient with a diagnosis of fibrosing PHS following a multidisciplinary discussion of diffuse interstitial lung disease hypersensitivity pneumonitis .
• Patient who had received an information note presenting the study and who had not expressed opposition to participating in this research.

You may not qualify if:

• Opposition of the patient to participate in the study,
• Patient under guardianship, curatorship or safeguard of justice,
• Patients who have moved within the last 12 months, or who plan to move within the next 6 months,
• Patients who have already had a visit from the indoor environment medical advisor.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Stéphanie DIROU, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie DIROU, PH

CONTACT

+33 2 53 48 27 74; stéphanie.dirou@chu-nantes.fr

François Xavier BLANC, PU PH

CONTACT

+33 2 40 16 52 36; xavier.blanc@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

FR (1)