Hypersensitivity PneumonitisPHSaDomNCT05988437
Contribution of the Indoor Environment Medical Advisor in the Management of Fibrosing Hypersensitivity Pneumonitis
An observational study of Hypersensitivity Pneumonitis, run by Nantes University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Pneumonitis
- How many people
- 100 participants
- Where
- 7 sitesFrance
- Study dates
- 16 Nov 2023to 16 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CH Ancenis
Ancenis
Carole HERVE, +33 2.44 76 85 06
Carole HERVE
- Recruiting
CHU Angers
Angers
Frédéric GAGNADOUX, +33 2 41 35 36 95, frederic.gagnadoux@chu-angers.fr
Frédéric GAGNADOUX
- Not yet recruiting
CH Chateaubriant
Châteaubriant
Arnaud CAVAILLES, +33 2 40 16 56 77, arnaud.cavailles@chu-nantes.fr
Arnaud CAVAILLES
- Recruiting
CHD LRSY
La Roche-sur-Yon
Cyril GUIBERT, +33 2 51 44 61 61, cyril.guibert@chd-vendee.fr
Cyril GUIBERT
- Recruiting
CH Cote de lumière
Les Sables-d'Olonne
Christine BEUCHARD, +33 2 51 21 86 67, christine.beuchard@ch-cotedelumiere.fr
Christine BEUCHARD
- Recruiting
CHU de Nantes
Nantes, Loire-Atlantique, 44093
Stéphanie DIROU, PH, stéphanie.dirou@chu-nantes.fr
Stéphanie DIROU
- Recruiting
CH St Nazaire
Saint-Nazaire
Judith PROVOOST, +33 2 72 27 82 59, j.provoost@ch-saintnazaire.fr
Judith PROVOOST
About this study
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.
Read more
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.
Read the 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 patient's 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 patient's 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 patient's 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.
- Conditions
- Hypersensitivity Pneumonitis
- Keywords
- Fibrosing, indoor environment medical advisor
- Medical subject headings
- Alveolitis, Extrinsic Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (10)
Measure the diagnostic contribution of electrostatic dust sensors in the identification of antigens in patients with fibrosing hypersensitivity pneumonitis
Measured: 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
Measured: 1 month
Measure the positivity rate of serum precipitins collected in a manner appropriate to the exposures found
Measured: 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
Measured: 12 months
Evaluate the clinical evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
Measured: 6 months
Evaluate the clinical evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
Measured: 12 months
Evaluate the functional evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
Measured: 6 months
Evaluate the functional evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
Measured: 12 months
Evaluate the scanographic evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
Measured: 6 months
Evaluate the scanographic evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start16 Nov 2023
- Primary completion16 May 2027 (estimated)
- Study completion16 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie DIROU, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988437
- Sponsor's protocol ID
- RC23_0282
- Acronym
- PHSaDom
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Indoor Environment Medical Advisor in the Management of Fibrosing Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT05988437
- Acronym / sponsor ID
- PHSaDom / RC23_0282
- Conditions
- Hypersensitivity Pneumonitis
- Keywords
- Fibrosing, indoor environment medical advisor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 16 May 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patient's 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 patient's 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 patient's 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 1 month
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.
10 secondary outcomes
Measure the diagnostic contribution of electrostatic dust sensors in the identification of antigens in patients with fibrosing hypersensitivity pneumonitis
Time frame: 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
Time frame: 1 month
Measure the positivity rate of serum precipitins collected in a manner appropriate to the exposures found
Time frame: 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
Time frame: 12 months
Evaluate the clinical evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
Time frame: 6 months
Evaluate the clinical evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
Time frame: 12 months
Evaluate the functional evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
Time frame: 6 months
Evaluate the functional evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
Time frame: 12 months
Evaluate the scanographic evolution of the patient with fibrosing PHS at 6 months after the environment medical advisor assessment
Time frame: 6 months
Evaluate the scanographic evolution of the patient with fibrosing PHS at 12 months after the environment medical advisor assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie DIROU, PH principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity Pneumonitis, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie DIROU, PH (+33 2 53 48 27 74, stéphanie.dirou@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.