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Compares treatment options for Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Official title Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT05674994
What this study is testing
What is Methylprednisone/Prednisone?
Methylprednisone/Prednisone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute exacerbation of idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Previous or concurrent diagnosis of IPF (a)
- Acute worsening or development of dyspnea typically \< 1-month duration
You likely can't join if
- 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...
- Active cancer
- Patient on a lung transplantation waiting list
See the full eligibility 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...
- 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...
- 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
- 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...
- 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 treatment clinical trial
- Documented pregnancy or lactation
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under court protection
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Besançon, France
- Bobigny, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- Grenoble, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Reims, France
- Rennes, France
- Rouen, France
+ 3 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Besançon, France; Bobigny, France; Bordeaux, France; Caen, France; Clermont-Ferrand, France and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.