Status:
NOT_YET_RECRUITING
"Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis"
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypersensitivity Pneumonitis
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Hypersensitivity Pneumonitis (HP) is an immune-mediated disease that manifests as interstitial lung disease after exposure to an inhaled antigen, often unidentified. HP can be classified as non-fibrot...
Detailed Description
Hypersensitivity Pneumonitis (HP) is an immune-mediated disease that manifests as interstitial lung disease after exposure to an inhaled antigen, often unidentified. HP can be classified as non-fibrot...
Eligibility Criteria
Inclusion
- Patient aged above 18 years and under 90 years old
- Diagnosis of fibrotic HP ("definite" or "high confidence") after MDD according to the criteria proposed by guidelines \[5\]
- Fibrosis extent ≥ 10% on chest HRCT
- Mild to moderate functional impairment defined by FVC ≥ 50% pred and DLco ≥ 30% pred
- Written informed consent for participation in study
- Patient affiliated to a social security scheme or CMU beneficiary
- Effective contraception for men and woman of childbearing age.
Exclusion
- Uncertain diagnosis of fibrotic HP ("low confidence" or "unlikely") after MDD according to the criteria proposed by guidelines \[5\].
- Severe functional impairment defined by FVC \< 50% pred and DLco \< 30% pred.
- Patient previously treated or currently being treated for fibrotic HP (with corticosteroids, any immunosuppressive agent, or anti- fibrotic therapies).
- Person under guardianship/ curatorship (sous tutelle/curatelle)
- Contraindication to corticosteroid therapy (hypersensitivity to the active substances or to one of the excipients, severe infections, psychotic states not controlled by treatment, live vaccines, uncontrolled diabetes mellitus and uncontrolled arterial hypertension.) or to auxiliary medicinal products
- Patient deprived of liberty under judicial or administrative decision
- Patient participating in another clinical trial with an investigational medicinal product. The patient may participate in another clinical trial after the 6 months of treatment in this study
- Pregnancy or breastfeeding woman
- Patient receiving AME (state medical assistance)
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07210008
Start Date
June 1 2026
End Date
December 1 2028
Last Update
October 7 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.