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AzTrials

Acute Exacerbation of Idiopathic Pulmonary FibrosisPhase 3EXAFIP2NCT05674994

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

A Phase 3 study testing Methylprednisone/Prednisone in people with Acute Exacerbation of Idiopathic Pulmonary Fibrosis, run by Fondation Hôpital Saint-Joseph at 29 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Methylprednisone/Prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
29 sitesFrance
Study dates
26 Oct 2023to 31 Dec 2026
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-Marc NACCACHE, MD contact

144126747 ext. +33

jmnaccache@ghpsj.fr

Helene BEAUSSIER, PharmD, PhD contact

144127883 ext. +33

crc@ghpsj.fr

29 sites in 1 country

France29 sites, 29 recruiting

  • CHU ANgers

    Angers

    Frederic GAGNADOUX

    Recruiting

  • CHU de Besancon

    Besançon

    Mathilde DUPREZ, MD

    Recruiting

  • Hôpital Avicenne

    Bobigny

    Hilario NUNES, MD

    Not yet recruiting

  • CHU BOrdeaux

    Bordeaux

    Elodie BLANCHARD, MD

    Recruiting

  • CHU Caen

    Caen

    Emmanuel BERGOT, MD

    Recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand

    Camille ROLLAND DEBORD, MD

    Not yet recruiting

  • CHIC

    Créteil

    Quentin GIBIOT, MD

    Recruiting

  • CHU de Dijon

    Dijon

    Philippe BONNIAUD, MD

    Recruiting

  • CHU Grenoble

    Grenoble

    Sebastien QUETANT, MD

    Not yet recruiting

  • CHRU Lille

    Lille

    Victor VALENTIN, MD

    Not yet recruiting

  • Hospices Civils de Lyon

    Lyon

    Vincent COTTIN, MD

    Recruiting

  • Hôpital Nord

    Marseille

    Martine REAYNAUD GAUBERT, MD

    Recruiting

  • CHU de Montpellier

    Montpellier

    Arnaud BOURDIN, MD

    Not yet recruiting

  • CHU Nancy

    Nancy

    Anne GUILLAUMOT, MD

    Recruiting

  • CHU de Nantes

    Nantes

    Stéphanie DIROU, MD

    Not yet recruiting

  • CHU Nice

    Nice

    Sylvie LEROY, MD

    Not yet recruiting

  • Hôpital Paris Saint-Joseph

    Paris, 75014

    Jean-Marc NACCACHE, MD

    Recruiting

  • Hôpital Bichat

    Paris

    Bruno CRESTANI, MD

    Recruiting

  • Hôpital Européen Georges Pompidou

    Paris

    Jean PASTRE, MD

    Recruiting

  • Hôpital FOCH

    Paris

    Alexandre CHABROL, MD

    Not yet recruiting

  • Hôpital Kremiln Bicetre

    Paris

    David MONTANI, MD

    Recruiting

  • Hôpital Saint-Louis

    Paris

    Abdellatif TAZI, MD

    Not yet recruiting

  • Hôpital Tenon

    Paris

    Jacques CADRANEL, MD

    Recruiting

  • CHU Reims

    Reims

    Francois LEBARGY, MD

    Recruiting

  • CHU Rennes

    Rennes

    Stephane JOUNEAU, MD

    Recruiting

  • CHU Rouen

    Rouen

    Stéphane DOMINIQUE, MD

    Not yet recruiting

  • CHU Strasbourg

    Strasbourg

    Sandrine HIRSCHI, MD

    Not yet recruiting

  • CHU Toulouse

    Toulouse

    Gregoire PREVOT, MD

    Recruiting

  • CHU Tours

    Tours

    Thomas FLAMENT, MD

    Not yet recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Methylprednisone/Prednisone, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylprednisone/PrednisoneDrug

    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.

  • PlaceboOther

    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.

Study groups in NCT05674994
Study groupRoleWhat they receive
MethylPrednisone/PrednisoneExperimental* 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.
Receives: Drug: Methylprednisone/Prednisone
PlaceboPlacebo comparator* Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo * From Day 4 to Day 30: Oral Prednisone-Placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of glucocorticoids compared to placebo on mortality

    This outcome corresponds to the all-cause mortality rate at day 30.

    Measured: Day 30

Secondary outcomes (21)

  1. 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.

    Measured: Day 30

  2. 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.

    Measured: Day 90

  3. Death or transplantation at Day 90

    This outcome corresponds to the vital status and transplantation at Day 90.

    Measured: Day90

  4. 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.

    Measured: Day 30

  5. 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.

    Measured: Day 90

  6. Time to worsening

    This outcome corresponds to the time (in days) from randomization to worsening from day4 to day30 (end of study treatment).

    Measured: Day30

  7. Percentage of patients admitted to ICU

    This outcome corresponds to the percentage of patients admitted to ICU from randomization to ICU's admission.

    Measured: Day90

  8. Percentage of patients requiring invasive ventilation

    This outcome corresponds to the percentage of patients requiring invasive ventilation from randomization to invasive ventilation.

    Measured: Day90

  9. Length of hospital stay

    This outcome corresponds to the length of hospital-stay: Time (in days) from randomization to hospital withdraw.

    Measured: Day 90

  10. 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.

    Measured: Day90

  11. 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.

    Measured: Day90

  12. 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.

    Measured: Day90

  13. Occurence of Infectious disease

    This outcome corresponds to the occurence of infectious disease from D1 to Day 90.

    Measured: Day 90

  14. 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.

    Measured: Day90

  15. 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.

    Measured: Day90

  16. Occurence of Neuropsychological disturbances

    This outcome corresponds to the occurence of neuropsychological disturbances from D1 to Day 90.

    Measured: Day90

  17. 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.

    Measured: Day 90

  18. 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.

    Measured: Day1, Day30, Day90

  19. 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).

    Measured: Day 90

  20. 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).

    Measured: Day90

  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.

    Measured: Day15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start26 Oct 2023
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05674994
Sponsor's protocol ID
EXAFIP2
Acronym
EXAFIP2
Status last verified
Feb 2026
First submitted
9 Dec 2022
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Naccache JM, Montil M, Cadranel J, Cachanado M, Cottin V, Crestani B, Valeyre D, Wallaert B, Simon T, Nunes H. Study protocol: exploring the efficacy of cyclophosphamide added to corticosteroids for treating acute exacerbation of idiopathic pulmonary fibrosis; a randomized double-blind, placebo-controlled, multi-center phase III trial (EXAFIP). BMC Pulm Med. 2019 Apr 11;19(1):75. doi: 10.1186/s12890-019-0830-x.

    PubMed 30971235

  • Naccache JM, Jouneau S, Didier M, Borie R, Cachanado M, Bourdin A, Reynaud-Gaubert M, Bonniaud P, Israel-Biet D, Prevot G, Hirschi S, Lebargy F, Marchand-Adam S, Bautin N, Traclet J, Gomez E, Leroy S, Gagnadoux F, Riviere F, Bergot E, Gondouin A, Blanchard E, Parrot A, Blanc FX, Chabrol A, Dominique S, Gibelin A, Tazi A, Berard L, Brillet PY, Debray MP, Rousseau A, Kerjouan M, Freynet O, Dombret MC, Gamez AS, Nieves A, Beltramo G, Pastre J, Le Borgne-Krams A, Degot T, Launois C, Plantier L, Wemeau-Stervinou L, Cadranel J, Chenivesse C, Valeyre D, Crestani B, Cottin V, Simon T, Nunes H; EXAFIP investigators and the OrphaLung network. Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Jan;10(1):26-34. doi: 10.1016/S2213-2600(21)00354-4. Epub 2021 Sep 7.

    PubMed 34506761

  • Raghu G, Remy-Jardin M, Myers JL, Richeldi L, Ryerson CJ, Lederer DJ, Behr J, Cottin V, Danoff SK, Morell F, Flaherty KR, Wells A, Martinez FJ, Azuma A, Bice TJ, Bouros D, Brown KK, Collard HR, Duggal A, Galvin L, Inoue Y, Jenkins RG, Johkoh T, Kazerooni EA, Kitaichi M, Knight SL, Mansour G, Nicholson AG, Pipavath SNJ, Buendia-Roldan I, Selman M, Travis WD, Walsh S, Wilson KC; American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68. doi: 10.1164/rccm.201807-1255ST.

    PubMed 30168753

  • Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI.

    PubMed 27299520

  • Kondoh Y, Azuma A, Inoue Y, Ogura T, Sakamoto S, Tsushima K, Johkoh T, Fujimoto K, Ichikado K, Matsuzawa Y, Saito T, Kishi K, Tomii K, Sakamoto N, Aoshima M, Araya J, Izumi S, Arita M, Abe M, Yamauchi H, Shindoh J, Suda T, Okamoto M, Ebina M, Yamada Y, Tohda Y, Kawamura T, Taguchi Y, Ishii H, Hashimoto N, Abe S, Taniguchi H, Tagawa J, Bessho K, Yamamori N, Homma S. Thrombomodulin Alfa for Acute Exacerbation of Idiopathic Pulmonary Fibrosis. A Randomized, Double-Blind Placebo-controlled Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1110-1119. doi: 10.1164/rccm.201909-1818OC.

    PubMed 31917621

  • Papiris SA, Kagouridis K, Kolilekas L, Papaioannou AI, Roussou A, Triantafillidou C, Baou K, Malagari K, Argentos S, Kotanidou A, Karakatsani A, Manali ED. Survival in Idiopathic pulmonary fibrosis acute exacerbations: the non-steroid approach. BMC Pulm Med. 2015 Dec 14;15:162. doi: 10.1186/s12890-015-0146-4.

    PubMed 26666385

  • Farrand E, Vittinghoff E, Ley B, Butte AJ, Collard HR. Corticosteroid use is not associated with improved outcomes in acute exacerbation of IPF. Respirology. 2020 Jun;25(6):629-635. doi: 10.1111/resp.13753. Epub 2019 Dec 17.

    PubMed 31846126

  • Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512.

    PubMed 23204124

  • Duchemann B, Annesi-Maesano I, Jacobe de Naurois C, Sanyal S, Brillet PY, Brauner M, Kambouchner M, Huynh S, Naccache JM, Borie R, Piquet J, Mekinian A, Virally J, Uzunhan Y, Cadranel J, Crestani B, Fain O, Lhote F, Dhote R, Saidenberg-Kermanac'h N, Rosental PA, Valeyre D, Nunes H. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017 Aug 3;50(2):1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug.

    PubMed 28775045

  • Cottin V, Crestani B, Cadranel J, Cordier JF, Marchand-Adam S, Prevot G, Wallaert B, Bergot E, Camus P, Dalphin JC, Dromer C, Gomez E, Israel-Biet D, Jouneau S, Kessler R, Marquette CH, Reynaud-Gaubert M, Aguilaniu B, Bonnet D, Carre P, Danel C, Faivre JB, Ferretti G, Just N, Lebargy F, Philippe B, Terrioux P, Thivolet-Bejui F, Trumbic B, Valeyre D. French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis - 2017 update. Full-length version. Rev Mal Respir. 2017 Oct;34(8):900-968. doi: 10.1016/j.rmr.2017.07.017. Epub 2017 Sep 20. No abstract available.

    PubMed 28939155

  • Idiopathic Pulmonary Fibrosis Clinical Research Network; Raghu G, Anstrom KJ, King TE Jr, Lasky JA, Martinez FJ. Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med. 2012 May 24;366(21):1968-77. doi: 10.1056/NEJMoa1113354. Epub 2012 May 20.

    PubMed 22607134

  • Collard HR, Moore BB, Flaherty KR, Brown KK, Kaner RJ, King TE Jr, Lasky JA, Loyd JE, Noth I, Olman MA, Raghu G, Roman J, Ryu JH, Zisman DA, Hunninghake GW, Colby TV, Egan JJ, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kondoh Y, Lynch DA, Muller-Quernheim J, Myers JL, Nicholson AG, Selman M, Toews GB, Wells AU, Martinez FJ; Idiopathic Pulmonary Fibrosis Clinical Research Network Investigators. Acute exacerbations of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2007 Oct 1;176(7):636-43. doi: 10.1164/rccm.200703-463PP. Epub 2007 Jun 21.

    PubMed 17585107

  • Collard HR, Yow E, Richeldi L, Anstrom KJ, Glazer C; IPFnet investigators. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res. 2013 Jul 13;14(1):73. doi: 10.1186/1465-9921-14-73.

    PubMed 23848435

  • Churg A, Muller NL, Silva CI, Wright JL. Acute exacerbation (acute lung injury of unknown cause) in UIP and other forms of fibrotic interstitial pneumonias. Am J Surg Pathol. 2007 Feb;31(2):277-84. doi: 10.1097/01.pas.0000213341.70852.9d.

    PubMed 17255773

  • Parambil JG, Myers JL, Ryu JH. Histopathologic features and outcome of patients with acute exacerbation of idiopathic pulmonary fibrosis undergoing surgical lung biopsy. Chest. 2005 Nov;128(5):3310-5. doi: 10.1378/chest.128.5.3310.

    PubMed 16304277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylprednisone/Prednisone in people with Acute Exacerbation of Idiopathic Pulmonary Fibrosis, run by Fondation Hôpital Saint-Joseph at 29 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 14 inclusion and 12 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jean-Marc NACCACHE, MD (144126747 ext. +33, jmnaccache@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of glucocorticoids compared to placebo on mortality (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05674994, which also lists 23 linked publications.

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 2 Mar 2026.

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