Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05988437
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-08-04
Brief Title:
Contribution of the Indoor Environment Medical Advisor in the Management of Fibrosing Hypersensitivity Pneumonitis
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Contribution of the Indoor Environment Medical Advisor in the Management of Fibrosing Hypersensitivity Pneumonitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHSaDom
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 patients 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 patients 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
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 patients 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 patients 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
Detailed Description:
Patients will be prospectively recruited as incidental cases during multidisciplinary discussions of diffuse interstitial lung disease organized on a regular monthly basis between university hospitals private lung specialists and those practising in outlying hospitals
Once the patients non-objection has been collected a medical self-exposure questionnaire will be completed and the antigens identified by the questionnaire will be listed time T1
As in current practice the indoor environment medical advisor CMEI will then visit the patients home to carry out an environmental audit including a macroscopic assessment and swabbing for any abnormalities that might suggest risky antigenic exposure The results of the swab analysis will be collected along with a number of antigens T2 time During this visit a sensor will be placed in the patients home for a period of 4 weeks and the results will be collected after 4 weeks in the home with a number of antigens time T3
Following these 3 evaluation times serum precipitins will be collected according to the antigens identified during the 3 visits
As part of the patient follow-up a telephone call by the CMEI at 6 months from the initial environmental audit will assess whether eviction of the identified antigens has been effective Similarly at 12 months the CMEI will make another home visit to assess the rate of eviction of the antigens identified at the initial visit
In parallel as part of routine care a clinical and functional evaluation will be carried out at diagnosis 6 months and 12 months A radiological assessment involving a chest CT scan will be performed at diagnosis and at 12 months
Once the patients non-objection has been collected a medical self-exposure questionnaire will be completed and the antigens identified by the questionnaire will be listed time T1
As in current practice the indoor environment medical advisor CMEI will then visit the patients home to carry out an environmental audit including a macroscopic assessment and swabbing for any abnormalities that might suggest risky antigenic exposure The results of the swab analysis will be collected along with a number of antigens T2 time During this visit a sensor will be placed in the patients home for a period of 4 weeks and the results will be collected after 4 weeks in the home with a number of antigens time T3
Following these 3 evaluation times serum precipitins will be collected according to the antigens identified during the 3 visits
As part of the patient follow-up a telephone call by the CMEI at 6 months from the initial environmental audit will assess whether eviction of the identified antigens has been effective Similarly at 12 months the CMEI will make another home visit to assess the rate of eviction of the antigens identified at the initial visit
In parallel as part of routine care a clinical and functional evaluation will be carried out at diagnosis 6 months and 12 months A radiological assessment involving a chest CT scan will be performed at diagnosis and at 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None