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

ConditionAcute Exacerbation of Idiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondation Hôpital Saint-Joseph

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Previous or concurrent diagnosis of IPF (a)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisone/Prednisone

    Drug

    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.

  • Placebo

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: MethylPrednisone/PrednisoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of glucocorticoids compared to placebo on mortality

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

Time frame
Day 30

Secondary outcomes

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.

Time frame
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.

Time frame
Day 90
3

Death or transplantation at Day 90

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

Time frame
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.

Time frame
Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondation Hôpital Saint-Joseph

Lead sponsor

Source ClinicalTrials.gov
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