Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Efficacy of Prednisolone Metasulfobenzoate Sodium vs Placebo in Adults with Fibrotic Hypersensitivity Pneumonitis: A Randomized Controlled Trial

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

A rare lung condition called fibrotic hypersensitivity pneumonitis occurs when the immune system reacts to inhaled particles, causing inflammation and scarring that make breathing difficult. The disease is usually identified by a team of specialists and can range from mild to moderate severity in adults who have not received prior treatment for the scarring form of the illness.

The study compares a steroid medication, prednisolone (provided as SOLUPRED 5 mg tablets), with a placebo to see whether the drug improves lung function over six months. Participants are randomly assigned to receive either the active drug or the placebo and take the assigned tablets daily. Visits are scheduled at the start of the study, after three months, six months, and one year to collect information and perform safety checks.

During the visits, lung capacity is measured with a test called FVC, which records the amount of air expelled in a forced breath, and gas‑exchange ability is assessed with DLco. Physical endurance is evaluated using the 6MWT, where the distance walked in six minutes is recorded. Quality of life related to breathing is surveyed with the SGRQ questionnaire. Any side effects such as weight gain or changes in blood pressure are also monitored throughout the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit (m0)

    You attend the first study visit after joining the trial. during this visit, a series of baseline measurements are performed.

    Your lung function is measured with spirometry (tests how much air you can exhale) and dlco (tests how well oxygen moves from your lungs into the blood).

    You complete a 6‑minute walk test, in which you walk as far as possible in six minutes while a technician records the distance.

    You answer two questionnaires about respiratory quality of life: the sgrq and the king’s brief ild.

    Your weight and blood pressure are recorded, and the investigator looks for any identifiable cause of your disease (causal antigen).

  2. Step 2

    Randomization and medication assignment

    Based on a computer‑generated random process, you are assigned to receive either the active drug prednisolone or a matching placebo.

    You are given a supply of oral tablets that dissolve in the mouth. the tablets are identical in appearance for both groups.

  3. Step 3

    Daily medication intake (first 6 months)

    If you are in the prednisolone group, you take a total of 40 mg each day, which corresponds to eight 5‑mg tablets, taken by mouth once daily.

    If you are in the placebo group, you take the same number of tablets on the same schedule.

    The medication is taken for a period of six months, unless your doctor decides to stop it earlier because of safety reasons.

  4. Step 4

    Month 3 visit (m3)

    Three months after the first visit, you return for a follow‑up assessment.

    Lung function tests (spirometry and dlco) are repeated to see how your lungs are responding.

    Your weight and blood pressure are measured again, and you are asked about any side effects such as weight gain or high blood pressure.

    Any adverse events that occurred since the last visit are recorded.

  5. Step 5

    Month 6 visit (m6)

    Six months after enrollment, you attend a comprehensive evaluation that includes the primary study measurement.

    The same lung function tests (spirometry and dlco) are performed, and the change in forced vital capacity (fvc) from the baseline visit is calculated.

    A 6‑minute walk test and the two quality‑of‑life questionnaires (sgrq and king’s brief ild) are repeated.

    Weight, blood pressure, and any side effects are checked again, and the need for any additional treatment is assessed.

  6. Step 6

    Month 12 visit (m12)

    One year after the start of the trial, you complete the final study visit.

    Lung function tests (spirometry and dlco) are performed a second time after the six‑month assessment.

    The 6‑minute walk test and both questionnaires are repeated to evaluate longer‑term changes.

    Weight, blood pressure, and any adverse events are recorded, and the overall outcome of the study treatment is documented.

  7. Step 7

    Possible additional treatment

    If your disease shows progression during the study, your doctor may consider starting a second‑line therapy such as additional corticosteroids, immunosuppressive drugs, or antifibrotic medication.

    This decision is made by your physician and is not part of the study medication schedule.

Who can join the trial?

8 criteria

  • Be between 18 and 90 years old.
  • Have a confirmed diagnosis of fibrotic Hypersensitivity Pneumonitis (HP) that doctors are “definite” or “high confidence” about after a multidisciplinary discussion (MDD), which means several specialists review the case together.
  • Show at least 10% of lung scarring, called fibrosis, on a special chest scan known as high‑resolution CT (HRCT).
  • Have mild to moderate breathing problems, measured by:
    • Forced vital capacity (FVC) of 50% or more of the value expected for a healthy person of the same age, height, and sex.
    • Diffusing capacity of the lungs for carbon monoxide (DLco) of 30% or more of the expected value.
    • Sign a written informed consent form agreeing to join the study.
    • Be covered by a social security plan or be a beneficiary of the French universal health coverage system (CMU).
    • Use effective birth control if you are a man or a woman who could become pregnant, to prevent pregnancy during the trial.

Who cannot join the trial?

9 criteria

  • Diagnosis of fibrotic Hypersensitivity Pneumonitis is not clear (low confidence) after a multidisciplinary discussion with doctors.
  • Severe lung function problems: forced vital capacity (FVC) less than 50% of the expected value or diffusing capacity (DLco) less than 30% of the expected value.
  • Already treated before or currently receiving treatment for fibrotic HP with corticosteroids (steroid medicines), any immunosuppressive (immune‑suppressing) drug, or anti‑fibrotic (anti‑scar) therapy.
  • Pregnant or breast‑feeding woman.
  • Adult under legal protection such as guardianship, curatorship, or a court‑ordered safeguard of justice.
  • Has a contraindication (reason not to use) to steroid therapy, including allergy to the medicine, severe infections, uncontrolled mental illness, recent live vaccine, uncontrolled diabetes, or uncontrolled high blood pressure.
  • Deprived of liberty because of a judicial or administrative decision (for example, in prison).
  • Currently taking part in another clinical trial with an investigational medicinal product (experimental drug).
  • Receiving state medical assistance (AME).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Solupred is an oral medication that contains prednisolone, a type of corticosteroid. In this study, it is given as a small tablet that dissolves in the mouth. The drug works by reducing inflammation and suppressing the immune system, which may help improve breathing and lung function in people with fibrotic hypersensitivity pneumonitis. The trial is testing whether taking this medication for six months leads to better lung capacity compared to not receiving the active drug.

What is already known about the treatment

SOLUPRED 5 mg, comprimé orodispersible - This medication is taken by mouth as an orodispersible tablet that melts in the mouth without water. It is an approved corticosteroid that is widely described in medical textbooks and guidelines. It is normally used to treat inflammatory and immune‑related diseases, and in this study it is being tested for fibrotic hypersensitivity pneumonitis. The drug works by attaching to glucocorticoid receptors inside cells, which changes the activity of genes that control inflammation, and it is classified as a glucocorticoid (corticosteroid) agent.

Investigated diseases

Fibrotic hypersensitivity pneumonitis - A lung condition caused by an immune reaction to inhaled particles such as mold, bird proteins, or chemicals. The reaction leads to inflammation that, over time, can result in scarring (fibrosis) of the lung tissue. Early stages often involve coughing, shortness of breath, and fatigue. As fibrosis develops, the lungs become less flexible, making breathing increasingly difficult. The disease may progress slowly, with symptoms gradually worsening over months or years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521591-64-00Protocol codeAPHP240908Estimated enrolment120 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.