Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05674994 En recrutement IDF

Titre

Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial

Type

Interventional

Pathologie

Fibrose
Fibrose pulmonaire
Fibrose pulmonaire idiopathique

Phase

Phase 3

Promoteur

Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)

Date de début

octobre 2023

Date de fin

décembre 2026

Dernière mise à jour

02 septembre 2025

Résumé

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.

Détail

Voir le détail Idiopathic pulmonary fibrosis (IPF) is the most frequent idiopathic interstitial lung disease (ILD) in adults. Its prognosis is poor with a median survival time ranging from 2 to 3 years. Acute exacerbation of IPF (IPF-AE) is defined as acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormalities. Recently, diagnosis criteria were defined now allowing standardized diagnosis of IPF-AE and thus its study. IPF-AE is a major event of the disease having a 5 to 10% annual incidence. In-hospital mortality after IPF-AE exceeds 50% and current evidence suggests that up to 46% of deaths in IPF patients are associated with IPF-AE. For the time being, no treatment has been proved to be effective in IPF-AE. While the clinical practice guideline suggests treatment with steroids, this recommendation is based only on expert opinion (low level evidence). Retrospective studies suggested the efficacy of thrombomodulin, cyclophosphamide or of therapeutic strategy including plasma exchange, rituximab and intravenous immunoglobulins. A recent Japanese randomized trial failed to show the efficacy of thrombomodulin alfa. Investigators performed a randomized trial assessing the role of cyclophosphamide on top of pulse steroid (EXAFIP-NCT02460588) and showed that cyclophosphamide did not reduce the 3-month mortality. A study assessing the effect of therapeutic plasma exchange, rituximab and intravenous immunoglobulins for severe form of IPF-AE patients admitted to Intensive Care Unit (ICU) is still ongoing (NCT03286556). Presently, the clinical benefit of corticosteroids is questioned. Indeed, 2 retrospective series reported an absence of outcome improvement by corticosteroids among IPF-AE patients and even suggested a potential detrimental outcome. It is therefore necessary to set-up a placebo-controlled randomized trial: investigator's goal is to test the hypothesis that a corticosteroid treatment is highly efficient in IPF-AE, compared to placebo. This underlines that, as no good evidence is available to support the use of glucocorticoids in IPF-AE, randomized controlled trials are also needed to address their efficacy and safety in this indication. The choices of glucocorticoids' dosage, primary objective (mortality) and primary assessment criteria (all cause mortality rate at Day 30) are driven by investigator's previous study, EXAFIP. In this study, glucocorticoids dosage was as follow: intravenous methylprednisolone, 10 mg/kg/d (without exceeding 1000 mg/d), 3 days in a row shift to prednisone at 1 mg/kg/d for 1 week, and 0.75 mg/kg/d for 1 week, then 0.5 mg/kg/d for 1 week, and 0.25 mg/kg/d for 1 week, and 10 mg/d if weight > 65 kg; 7.5 mg if weight ≤ 65 kg until M6. The 1-month mortality of patient under this high dose of glucocorticoids was 20%. In view of the poor prognosis of IPF-AE, it seems also important to evaluate the effect of treatment on overall mortality at Day 90. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL	Quentin GIBIOT	Active, sans recrutement	29/03/2024 01:30:41	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Europeen Georges Pompidou	Jean PASTRE, MD			Contact (sur clinicalTrials)
AP-HP - Hôpital Saint Louis	Abdellatif TAZI, MD			Contact (sur clinicalTrials)
AP-HP - Hôpital Tenon	Jacques CADRANEL, MD			Contact (sur clinicalTrials)
CHU NANCY	Anne GUILLAUMOT, MD			Contact (sur clinicalTrials)
HOPITAL FOCH	Alexandre CHABROL, MD			Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU BOrdeaux - Bordeaux 3031582 - France	Elodie BLANCHARD, MD			Contact (sur clinicalTrials)
CHU de Montpellier - Montpellier 2992166 - France	Arnaud BOURDIN, MD			Contact (sur clinicalTrials)
CHU de Nantes - Nantes 2990969 - France	Stéphanie DIROU, MD			Contact (sur clinicalTrials)
CHU Reims - Reims 2984114 - France	Francois LEBARGY, MD			Contact (sur clinicalTrials)
CHU Rennes - Rennes 2983990 - France	Stephane JOUNEAU, MD			Contact (sur clinicalTrials)
CHU Rouen - Rouen 2982652 - France	Stéphane DOMINIQUE, MD			Contact (sur clinicalTrials)
CHU Toulouse - Toulouse 2972315 - France	Gregoire PREVOT, MD			Contact (sur clinicalTrials)
Hospices Civils de Lyon - Lyon 2996944 - France	Vincent COTTIN, MD			Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHIC - Créteil 3022530 - France	Quentin GIBIOT, MD			Contact (sur clinicalTrials)
CHRU Lille - Lille 2998324 - France	Victor VALENTIN, MD			Contact (sur clinicalTrials)
CHU ANgers - Angers 3037656 - France	Frederic GAGNADOUX			Contact (sur clinicalTrials)
CHU Caen - Caen 3029241 - France	Emmanuel BERGOT, MD			Contact (sur clinicalTrials)
CHU Clermont-Ferrand - Clermont-Ferrand 3024635 - France	Camille ROLLAND DEBORD, MD			Contact (sur clinicalTrials)
CHU de Besancon - Besançon 3033123 - France	Mathilde DUPREZ, MD			Contact (sur clinicalTrials)
CHU de Dijon - Dijon 3021372 - France	Philippe BONNIAUD, MD			Contact (sur clinicalTrials)
CHU Grenoble - Grenoble 3014728 - France	Sebastien QUETANT, MD			Contact (sur clinicalTrials)
CHU Nice - Nice 2990440 - France	Sylvie LEROY, MD			Contact (sur clinicalTrials)
CHU Strasbourg - Strasbourg 2973783 - France	Sandrine HIRSCHI, MD			Contact (sur clinicalTrials)
CHU Tours - Tours 2972191 - France	Thomas FLAMENT, MD			Contact (sur clinicalTrials)
Hôpital Avicenne - Bobigny 3032179 - France	Hilario NUNES, MD			Contact (sur clinicalTrials)
Hôpital Bichat - Paris 2988507 - France	Bruno CRESTANI, MD			Contact (sur clinicalTrials)
Hôpital Kremiln Bicetre - Paris 2988507 - France	David MONTANI, MD			Contact (sur clinicalTrials)
Hôpital Nord - Marseille 2995469 - France	Martine REAYNAUD GAUBERT, MD			Contact (sur clinicalTrials)
Hôpital Paris Saint-Joseph - 75014 - Paris 2988507 - France	Jean-Marc NACCACHE, MD			Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

1. Patient is ≥ 18 years of age

2. IPF or IPF (likely) diagnosis defined on 2018 international recommendations

3. Definite or suspected Acute Exacerbation defined by the international working group
criteria after exclusion of alternative diagnoses of acute worsening

*The criteria of IPF-AE are as follows:

- Previous or concurrent diagnosis of IPF (a)

- Acute worsening or development of dyspnea typically < 1-month duration

- Computed tomography with new bilateral ground-glass opacity and/or
consolidation superimposed on a background pattern consistent with usual
interstitial pneumonia pattern (b)

- Deterioration not fully explained by cardiac failure or fluid overload Patients
who fail to meet all 4 criteria due to missing computed tomography should be
considered as having "suspected Acute Exacerbation".

1. If the diagnosis of IPF is not previously established, this criterion can
be met by the presence of radiologic and/or histopathologic changes
consistent with usual interstitial pneumonia pattern on the current
evaluation.

2. If no previous computed tomography is available, the qualifier "new" can
be dropped from the third criterion.

4. For women of childbearing age: efficient contraception for the duration of the
study*

*Effective contraception is defined as any contraceptive method that is used
consistently and appropriately and has a low failure rate (i.e., less than 1% per
year)

5. Affiliation to the social security

6. Patient able to understand and sign a written informed consent form or in case of
incapacity of the patient to a relative whom understand and sign a written informed
consent form

Exclusion Criteria:

Critère de non inclusion

1. Identified etiology for acute worsening (i.e.: infectious disease)

2. Known hypersensitivity to glucocorticoids or to any component of the study treatment

3. Patient requiring mechanical ventilation or already on mechanical ventilation

4. Active bacterial, viral, fungal or parasitic infection. On swab collected, only
positive for SARS-CoV-2, Influenzae A, Influenzae B and Respiratory Syncytial Virus
(RSV) result, are considered active viral infection. The others viruses (i.e.
Rhinovirus, Adenovirus…) are not considered to be responsible of pneumonia.

5. Active cancer

6. Patient on a lung transplantation waiting list

7. Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days

8. Patient participating to another interventional clinical trial

9. Documented pregnancy or lactation

10. Patient under tutorship or curatorship

11. Patient deprived of liberty

12. Patient under court protection

NCT05674994 - Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial

Informations générales
Etablissements
Critères
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