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Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis (EXAFIP2)

Primary Purpose

Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methylprednisone/Prednisone
Placebo
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is ≥ 18 years of age IPF or IPF (likely) diagnosis defined on 2018 international recommendations 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". 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. If no previous computed tomography is available, the qualifier "new" can be dropped from the third criterion. 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) Affiliation to the social security 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: Identified etiology for acute worsening (i.e.: infectious disease) Known hypersensitivity to glucocorticoids or to any component of the study treatment Patient requiring mechanical ventilation or already on mechanical ventilation 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. Active cancer Patient on a lung transplantation waiting list Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days Patient participating to another interventional clinical trial Documented pregnancy or lactation Patient under tutorship or curatorship Patient deprived of liberty Patient under court protection

Sites / Locations

  • CHU ANgers
  • CHU de Besancon
  • Hôpital Avicenne
  • CHU BOrdeaux
  • CHU Caen
  • CHU Clermont-Ferrand
  • CHIC
  • CHU de Dijon
  • CHU Grenoble
  • CHRU Lille
  • Hospices Civils de Lyon
  • Hôpital Nord
  • CHU de Montpellier
  • CHU Nancy
  • CHU de Nantes
  • CHU Nice
  • Groupe Hospitalier Paris Saint-Joseph
  • Hôpital Bichat
  • Hôpital Européen Georges Pompidou
  • Hôpital FOCH
  • Hôpital Kremiln Bicetre
  • Hôpital Saint-Louis
  • Hôpital Tenon
  • CHU Reims
  • CHU Rennes
  • CHU Rouen
  • CHU Strasbourg
  • CHU Toulouse
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MethylPrednisone/Prednisone

Placebo

Arm Description

Day 1, 2 and 3: Intravenous Methylprednisolone 10 mg/kg/d (without exceeding 1000 mg/d) Vials of injectable solution of methylprednisolone® are diluted in 100 ml of NaCl 0.9% or G5%. Perfusion duration is between 20 to 30 minutes. The commercialized form for methylprednisolone injectable solution is not imposed and is taken from the stock of each pharmacy of the participating centers. From day 4 to Day 30: Oral Prednisone slow tappering 1 mg/kg/d for 7 days 0.5 mg/kg/d for 7 days 0.25 mg/kg/d for 7 days, 10 mg/d until Day 30. For 10mg/kg, 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg; rounding to 5 decimal lower if decimal ≤ 7 and the top ten if decimal ≥ 8.

Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo From Day 4 to Day 30: Oral Prednisone-Placebo

Outcomes

Primary Outcome Measures

Efficacy of glucocorticoids compared to placebo on mortality
This outcome corresponds to the all-cause mortality rate at day 30.

Secondary Outcome Measures

Time to death at Day 30
This outcome corresponds to the vital status assessment at Day 30 with time (in days) between randomization and death.
Time to death at Day 90
This outcome corresponds to the vital status assessment at Day 90 with time (in days) between randomization and death.
Death or transplantation at Day 90
This outcome corresponds to the vital status and transplantation at Day 90.
Respiratory disease-specific mortality rate at Day 30
This outcome corresponds to the mortality linked to the respiratory disease: cause of death assessment at Day 30.
Respiratory disease-specific mortality rate at Day 90
This outcome corresponds to the mortality linked to the respiratory disease: cause of death assessment at Day 90.
Time to worsening
This outcome corresponds to the time (in days) from randomization to worsening from day4 to day30 (end of study treatment).
Percentage of patients admitted to ICU
This outcome corresponds to the percentage of patients admitted to ICU from randomization to ICU's admission.
Percentage of patients requiring invasive ventilation
This outcome corresponds to the percentage of patients requiring invasive ventilation from randomization to invasive ventilation.
Length of hospital stay
This outcome corresponds to the length of hospital-stay: Time (in days) from randomization to hospital withdraw.
Radiological evolution
This outcome corresponds to the progression of pulmonary fibrosis: Chest HRCT scan comparison before Acute Exacerbation (if available) and at Day 90. Chest CT scans exacerbation, were analyzed by 2 thoracic radiologists' expert in interstitial lung diseases (PYBrillet, MPDebray). Before chest CT scans were evaluated for the pattern of ILD, according to the 2018 ATS/ERS classification for the diagnosis of IPF. The extent of interstitial fibrosing features on "Before" and "D90" CT scan was calculated by summing the extent of honeycombing, the extent of ground glass attenuation causing traction bronchiectasis both to the nearest 5% of the whole lungs, and the extent of reticular opacities. For this latter, the extension was estimated to the nearest 10% at three lung zones (delimited by the carina and the lowest inferior pulmonary vein for both lungs) and averaged between these 3 zones.
Pulmonary function tests evolution: Forced Vital Capacity
This outcome corresponds to the Absolute change in percent Forced Vital Capacity: Pulmonary function tests (PFTs) comparison before Acute Exacerbation (if available) and at Day 90.
Pulmonary function tests evolution: DLCO
This outcome corresponds to the Absolute change in percent DLCO: Pulmonary function tests (PFTs) comparison before Acute Exacerbation (if available) and at Day 90.
Occurence of Infectious disease
This outcome corresponds to the occurence of infectious disease from D1 to Day 90.
Occurence of Diabetes mellitus
This outcome corresponds to the occurence of diabetes mellitus by Capillary blood glucose monitoring and/or fasting blood glucose daily from D1 to Day 90.
Occurence of Cardiovascular disorder
This outcome corresponds to the occurence of cardiovascular disorder (heart rate, blood pressure, clinical history daily) from D1 to Day 90.
Occurence of Neuropsychological disturbances
This outcome corresponds to the occurence of neuropsychological disturbances from D1 to Day 90.
Occurence of Clinical laboratory evaluation
This outcome corresponds to the occurence of clinical laboratory evolution (blood count, serum chemistries and creatinin measurement) from Day 4 to Day 90.
Compare both arms in terms of Dyspnea
This outcome corresponds to the 0-100-mm visual analogue (VAS) scale anchored with 0 ''no breathlessness'' and 10 or 100 ''worst imaginable breathlessness", at Day1, Day 30 and Day 90.
Compare both arms in terms of Anxiety
This outcome corresponds to theHospital Anxiety and Depression Scale (HADs), daily from randomization to hospital withdraw, Day 30 and Day 90. The HAD scale is an instrument that screens for anxiety and depressive disorders. It includes 14 questions rated from 0 to 3. Seven questions relate to anxiety (Total A) and seven others to the depressive dimension (Total D), thus making it possible to obtain both scores (maximum score for each score = 21).
Compare both arms in terms of Depression
This outcome corresponds to the Anxiety and Depression Scale (HADs), from Day 1 to Day 90. The HAD scale is an instrument that screens for anxiety and depressive disorders. It includes 14 questions rated from 0 to 3. Seven questions relate to anxiety (Total A) and seven others to the depressive dimension (Total D), thus making it possible to obtain both scores (maximum score for each score = 21).
Compare both arms in terms of Clinical status at day 15
This outcome corresponds to the -category ordinal scale: 1: not hospitalized and no limitations of activities, 2: not hospitalized, with limitations of activities, home oxygen requirement, or both, 3: hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedicala reason, 4: hospitalized requiring any supplemental oxygen, 5: hospitalized, requiring use of high high-flow oxygen device or noninvasive ventilation, 6: hospitalize, receiving invasive mechanicalventilation or extra corporeal membrane oxygenation (ECMO), 7: death.

Full Information

First Posted
December 9, 2022
Last Updated
August 24, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT05674994
Brief Title
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Acronym
EXAFIP2
Official Title
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 14, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MethylPrednisone/Prednisone
Arm Type
Experimental
Arm Description
Day 1, 2 and 3: Intravenous Methylprednisolone 10 mg/kg/d (without exceeding 1000 mg/d) Vials of injectable solution of methylprednisolone® are diluted in 100 ml of NaCl 0.9% or G5%. Perfusion duration is between 20 to 30 minutes. The commercialized form for methylprednisolone injectable solution is not imposed and is taken from the stock of each pharmacy of the participating centers. From day 4 to Day 30: Oral Prednisone slow tappering 1 mg/kg/d for 7 days 0.5 mg/kg/d for 7 days 0.25 mg/kg/d for 7 days, 10 mg/d until Day 30. For 10mg/kg, 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg; rounding to 5 decimal lower if decimal ≤ 7 and the top ten if decimal ≥ 8.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo From Day 4 to Day 30: Oral Prednisone-Placebo
Intervention Type
Drug
Intervention Name(s)
Methylprednisone/Prednisone
Intervention Description
Patients will be enrolled during their hospitalization in pneumology department, as part of current practice, within 7 days of the screening visit. The investigator will perform randomization by connecting to the eCRF, randomization be stratified for the severity of IPF and the treatment with antifibrotic therapy (Nintedanib or Pirfenidone) (yes/no). If patient is randomized in Glucocorticoids Group: Day 1, 2 and 3: Intravenous Methylprednisolone 10 mg/kg/d (without exceeding 1000 mg/d). Vials of injectable solution of methylprednisolone® are diluted in 100 ml of NaCl 0.9% or G5%. Perfusion duration is between 20 to 30 minutes. From day 4 to Day 30: Oral Prednisone slow tappering 1 mg/kg/d for 7 days 0.5 mg/kg/d for 7 days 0.25 mg/kg/d for 7 days, 10 mg/d until Day 30. For 10mg/kg, 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg; rounding to 5 decimal lower if decimal ≤ 7 and the top ten if decimal ≥ 8.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will be enrolled during their hospitalization in pneumology department, as part of current practice, within 7 days of the screening visit. The investigator will perform randomization by connecting to the eCRF, randomization be stratified for the severity of IPF and the treatment with antifibrotic therapy (Nintedanib or Pirfenidone) (yes/no). If patient is randomized in Placebo Group: Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo From Day 4 to Day 30: Oral Prednisone-Placebo The Methylprednisolone-Placebo corresponds to 100 ml of NaCl 0.9 % or G5%. Perfusion duration is between 20 to 30 minutes. For the Prednisone-Placebo, the placebo was an oral solution formulated with a bittering agent (pharmaceutical excipient). Specifically, in place of prednisone, sucrose octaacetate (defined as a GRAS-'Generally Recognized as Safe' excipient by the EMA) was used at 5 mg/mL.
Primary Outcome Measure Information:
Title
Efficacy of glucocorticoids compared to placebo on mortality
Description
This outcome corresponds to the all-cause mortality rate at day 30.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Time to death at Day 30
Description
This outcome corresponds to the vital status assessment at Day 30 with time (in days) between randomization and death.
Time Frame
Day 30
Title
Time to death at Day 90
Description
This outcome corresponds to the vital status assessment at Day 90 with time (in days) between randomization and death.
Time Frame
Day 90
Title
Death or transplantation at Day 90
Description
This outcome corresponds to the vital status and transplantation at Day 90.
Time Frame
Day90
Title
Respiratory disease-specific mortality rate at Day 30
Description
This outcome corresponds to the mortality linked to the respiratory disease: cause of death assessment at Day 30.
Time Frame
Day 30
Title
Respiratory disease-specific mortality rate at Day 90
Description
This outcome corresponds to the mortality linked to the respiratory disease: cause of death assessment at Day 90.
Time Frame
Day 90
Title
Time to worsening
Description
This outcome corresponds to the time (in days) from randomization to worsening from day4 to day30 (end of study treatment).
Time Frame
Day30
Title
Percentage of patients admitted to ICU
Description
This outcome corresponds to the percentage of patients admitted to ICU from randomization to ICU's admission.
Time Frame
Day90
Title
Percentage of patients requiring invasive ventilation
Description
This outcome corresponds to the percentage of patients requiring invasive ventilation from randomization to invasive ventilation.
Time Frame
Day90
Title
Length of hospital stay
Description
This outcome corresponds to the length of hospital-stay: Time (in days) from randomization to hospital withdraw.
Time Frame
Day 90
Title
Radiological evolution
Description
This outcome corresponds to the progression of pulmonary fibrosis: Chest HRCT scan comparison before Acute Exacerbation (if available) and at Day 90. Chest CT scans exacerbation, were analyzed by 2 thoracic radiologists' expert in interstitial lung diseases (PYBrillet, MPDebray). Before chest CT scans were evaluated for the pattern of ILD, according to the 2018 ATS/ERS classification for the diagnosis of IPF. The extent of interstitial fibrosing features on "Before" and "D90" CT scan was calculated by summing the extent of honeycombing, the extent of ground glass attenuation causing traction bronchiectasis both to the nearest 5% of the whole lungs, and the extent of reticular opacities. For this latter, the extension was estimated to the nearest 10% at three lung zones (delimited by the carina and the lowest inferior pulmonary vein for both lungs) and averaged between these 3 zones.
Time Frame
Day90
Title
Pulmonary function tests evolution: Forced Vital Capacity
Description
This outcome corresponds to the Absolute change in percent Forced Vital Capacity: Pulmonary function tests (PFTs) comparison before Acute Exacerbation (if available) and at Day 90.
Time Frame
Day90
Title
Pulmonary function tests evolution: DLCO
Description
This outcome corresponds to the Absolute change in percent DLCO: Pulmonary function tests (PFTs) comparison before Acute Exacerbation (if available) and at Day 90.
Time Frame
Day90
Title
Occurence of Infectious disease
Description
This outcome corresponds to the occurence of infectious disease from D1 to Day 90.
Time Frame
Day 90
Title
Occurence of Diabetes mellitus
Description
This outcome corresponds to the occurence of diabetes mellitus by Capillary blood glucose monitoring and/or fasting blood glucose daily from D1 to Day 90.
Time Frame
Day90
Title
Occurence of Cardiovascular disorder
Description
This outcome corresponds to the occurence of cardiovascular disorder (heart rate, blood pressure, clinical history daily) from D1 to Day 90.
Time Frame
Day90
Title
Occurence of Neuropsychological disturbances
Description
This outcome corresponds to the occurence of neuropsychological disturbances from D1 to Day 90.
Time Frame
Day90
Title
Occurence of Clinical laboratory evaluation
Description
This outcome corresponds to the occurence of clinical laboratory evolution (blood count, serum chemistries and creatinin measurement) from Day 4 to Day 90.
Time Frame
Day 90
Title
Compare both arms in terms of Dyspnea
Description
This outcome corresponds to the 0-100-mm visual analogue (VAS) scale anchored with 0 ''no breathlessness'' and 10 or 100 ''worst imaginable breathlessness", at Day1, Day 30 and Day 90.
Time Frame
Day1, Day30, Day90
Title
Compare both arms in terms of Anxiety
Description
This outcome corresponds to theHospital Anxiety and Depression Scale (HADs), daily from randomization to hospital withdraw, Day 30 and Day 90. The HAD scale is an instrument that screens for anxiety and depressive disorders. It includes 14 questions rated from 0 to 3. Seven questions relate to anxiety (Total A) and seven others to the depressive dimension (Total D), thus making it possible to obtain both scores (maximum score for each score = 21).
Time Frame
Day 90
Title
Compare both arms in terms of Depression
Description
This outcome corresponds to the Anxiety and Depression Scale (HADs), from Day 1 to Day 90. The HAD scale is an instrument that screens for anxiety and depressive disorders. It includes 14 questions rated from 0 to 3. Seven questions relate to anxiety (Total A) and seven others to the depressive dimension (Total D), thus making it possible to obtain both scores (maximum score for each score = 21).
Time Frame
Day90
Title
Compare both arms in terms of Clinical status at day 15
Description
This outcome corresponds to the -category ordinal scale: 1: not hospitalized and no limitations of activities, 2: not hospitalized, with limitations of activities, home oxygen requirement, or both, 3: hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedicala reason, 4: hospitalized requiring any supplemental oxygen, 5: hospitalized, requiring use of high high-flow oxygen device or noninvasive ventilation, 6: hospitalize, receiving invasive mechanicalventilation or extra corporeal membrane oxygenation (ECMO), 7: death.
Time Frame
Day15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is ≥ 18 years of age IPF or IPF (likely) diagnosis defined on 2018 international recommendations 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". 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. If no previous computed tomography is available, the qualifier "new" can be dropped from the third criterion. 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) Affiliation to the social security 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: Identified etiology for acute worsening (i.e.: infectious disease) Known hypersensitivity to glucocorticoids or to any component of the study treatment Patient requiring mechanical ventilation or already on mechanical ventilation 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. Active cancer Patient on a lung transplantation waiting list Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days Patient participating to another interventional clinical trial Documented pregnancy or lactation Patient under tutorship or curatorship Patient deprived of liberty Patient under court protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc NACCACHE, MD
Phone
144126747
Ext
+33
Email
jmnaccache@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Helene BEAUSSIER, PharmD, PhD
Phone
144127883
Ext
+33
Email
crc@ghpsj.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc NACCACHE
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Study Director
Facility Information:
Facility Name
CHU ANgers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic GAGNADOUX
Facility Name
CHU de Besancon
City
Besançon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde DUPREZ, MD
Facility Name
Hôpital Avicenne
City
Bobigny
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilario NUNES, MD
Facility Name
CHU BOrdeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie BLANCHARD, MD
Facility Name
CHU Caen
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel BERGOT, MD
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille ROLLAND DEBORD, MD
Facility Name
CHIC
City
Créteil
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quentin GIBIOT, MD
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe BONNIAUD, MD
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien QUETANT, MD
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor VALENTIN, MD
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent COTTIN, MD
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine REAYNAUD GAUBERT, MD
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud BOURDIN, MD
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne GUILLAUMOT, MD
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie DIROU, MD
Facility Name
CHU Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie LEROY, MD
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc NACCACHE, MD
Facility Name
Hôpital Bichat
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno CRESTANI, MD
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean PASTRE, MD
Facility Name
Hôpital FOCH
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre CHABROL, MD
Facility Name
Hôpital Kremiln Bicetre
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David MONTANI, MD
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdellatif TAZI, MD
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques CADRANEL, MD
Facility Name
CHU Reims
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois LEBARGY, MD
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane JOUNEAU, MD
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane DOMINIQUE, MD
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine HIRSCHI, MD
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregoire PREVOT, MD
Facility Name
CHU Tours
City
Tours
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas FLAMENT, MD

12. IPD Sharing Statement

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Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

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