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Can steroids save lives during IPF Flare-Ups? new trial aims to find out

NCT ID NCT05674994

Disease control Sponsor: Fondation Hôpital Saint-Joseph Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether high-dose steroids (methylprednisolone and prednisone) can reduce deaths within 30 days for people hospitalized with a sudden worsening of idiopathic pulmonary fibrosis (IPF). About 110 adults with IPF and an acute exacerbation will receive either steroids or a placebo. Currently, no proven treatment exists for these dangerous episodes, which have a high short-term death rate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone and Prednisone (corticosteroids)
What this could lead to
If successful, this could confirm that steroids improve survival during sudden worsening of IPF, offering a standard treatment for these dangerous flare-ups.
What could go wrong
This is a relatively small Phase 3 trial (110 people). Steroids may not improve survival and could have harmful side effects, as seen with other immunosuppressants in stable IPF.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: 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

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute exacerbation of idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHIC

    RECRUITING

    Créteil, France

  • CHRU Lille

    NOT_YET_RECRUITING

    Lille, France

  • CHU ANgers

    RECRUITING

    Angers, France

  • CHU BOrdeaux

    RECRUITING

    Bordeaux, France

  • CHU Caen

    RECRUITING

    Caen, France

  • CHU Clermont-Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • CHU Grenoble

    NOT_YET_RECRUITING

    Grenoble, France

  • CHU Nancy

    RECRUITING

    Nancy, France

  • CHU Nice

    NOT_YET_RECRUITING

    Nice, France

  • CHU Reims

    RECRUITING

    Reims, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • CHU Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • CHU Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, France

  • CHU Toulouse

    RECRUITING

    Toulouse, France

  • CHU Tours

    NOT_YET_RECRUITING

    Tours, France

  • CHU de Besancon

    RECRUITING

    Besançon, France

  • CHU de Dijon

    RECRUITING

    Dijon, France

  • CHU de Montpellier

    NOT_YET_RECRUITING

    Montpellier, France

  • CHU de Nantes

    NOT_YET_RECRUITING

    Nantes, France

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, France

  • Hôpital Avicenne

    NOT_YET_RECRUITING

    Bobigny, France

  • Hôpital Bichat

    RECRUITING

    Paris, France

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • Hôpital FOCH

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital Kremiln Bicetre

    RECRUITING

    Paris, France

  • Hôpital Nord

    RECRUITING

    Marseille, France

  • Hôpital Paris Saint-Joseph

    RECRUITING

    Paris, 75014, France

  • Hôpital Saint-Louis

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital Tenon

    RECRUITING

    Paris, France

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