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Steroid showdown: can prednisolone save lungs in rare fibrotic disease?

NCT ID NCT07210008

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the steroid prednisolone can slow the decline in lung function for people with fibrotic hypersensitivity pneumonitis, a lung disease caused by inhaling certain substances. About 120 adults with mild to moderate lung impairment will receive either prednisolone or a placebo for 6 months. The main goal is to see if the treatment helps preserve breathing capacity better than a dummy pill.

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 120 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 to 90 years

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: * Patient aged above 18 years and under 90 years old * Diagnosis of fibrotic HP ("definite" or "high confidence") after MDD according to the criteria proposed by guidelines \[5\] * Fibrosis extent ≥ 10% on chest HRCT * Mild to moderate functional impairment defined by FVC ≥ 50% pred and DLco ≥ 30% pred * Written informed consent for participation in study * Patient affiliated to a social security scheme or CMU beneficiary * Effective contraception for men and woman of childbearing age. Exclusion Criteria: * Uncertain diagnosis of fibrotic HP ("low confidence" or "unlikely") after MDD according to the criteria proposed by guidelines \[5\]. * Severe functional impairment defined by FVC \< 50% pred and DLco \< 30% pred. * Patient previously treated or currently being treated for fibrotic HP (with corticosteroids, any immunosuppressive agent, or anti- fibrotic therapies). * Person under guardianship/ curatorship (sous tutelle/curatelle) * Contraindication to corticosteroid therapy (hypersensitivity to the active substances or to one of the excipients, severe infections, psychotic states not controlled by treatment, live vaccines, uncontrolled diabetes mellitus and uncontrolled arterial hypertension.) or to auxiliary medicinal products * Patient deprived of liberty under judicial or administrative decision * Patient participating in another clinical trial with an investigational medicinal product. The patient may participate in another clinical trial after the 6 months of treatment in this study * Pregnancy or breastfeeding woman * Patient receiving AME (state medical assistance)

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Conditions

The condition(s) this trial relates to.

fibrotic hypersensitivity pneumonitis hypersensitivity pneumonitis

As listed by the trial registrant

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

Hypersensitivity pneumonitis

How to take part

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  1. The official record

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  2. A doctor treating you

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