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Study of hydroxychloroquine with low-dose corticosteroids compared to medium-dose corticosteroids in patients with pulmonary sarcoidosis

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on treating patients with pulmonary sarcoidosis, a condition where inflammatory cells form small lumps called granulomas in the lungs. The study compares two treatment approaches: a combination of hydroxychloroquine with low-dose prednisone versus medium-dose prednisone alone. The purpose is to determine if the combination treatment works as effectively as the standard treatment with medium-dose prednisone in improving breathing function.

The study evaluates how well patients' lung function improves over a period of 6 months. Participants receive either the combination of hydroxychloroquine and low-dose prednisone or medium-dose prednisone alone. The medications are taken by mouth daily. The treatment continues for 24 months while doctors monitor the patients' progress.

Throughout the study, doctors track various aspects of the disease, including breathing capacity, quality of life, and any potential side effects from the medications. They also monitor how the disease affects different parts of the body and measure various indicators in the blood that show how active the disease is. This helps determine how well each treatment approach is working for the patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo an evaluation to confirm pulmonary sarcoidosis diagnosis according to specific medical criteria

    Your lung function will be measured through breathing tests to determine your baseline Forced Vital Capacity (FVC)

    You will complete several questionnaires about your quality of life and symptoms

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: hydroxychloroquine combined with low-dose corticosteroids (prednisone)

    Group 2: medium-dose corticosteroids (prednisone) alone

    All medications will be taken by mouth

  3. Step 3

    3-month check-up

    Your breathing function will be assessed through tests including:

    Lung capacity measurements

    Walking test (6 minutes)

    Oxygen level check

    Review of any side effects from the medication

  4. Step 4

    6-month evaluation

    Final assessment of your lung function

    Completion of quality of life questionnaires

    Evaluation of treatment side effects

    Assessment of medication adherence

    Blood tests to check disease activity

  5. Step 5

    Monitoring throughout the study

    Regular checks for potential side effects of medications

    Tracking of any changes in your sarcoidosis symptoms

    Assessment of your overall health status

    Documentation of any additional treatments needed

Who can join the trial?

10 criteria

  • Age between 18 and 80 years
  • Diagnosed with pulmonary sarcoidosis according to ATS 2020 criteria, which means:
    • Having symptoms that match the condition
    • Presence of small inflammatory clusters in at least one tissue
    • Other similar conditions must be ruled out
    • Must have the following conditions:
      • Signs of lung involvement visible on medical imaging (such as small spots, cloudy areas, or line patterns)
      • Reduced lung capacity shown by breathing tests (FVC ≤80% of normal) or a significant drop in lung capacity in the past year
      • At least one breathing-related symptom such as cough, shortness of breath, or chest pain
      • Women who can become pregnant must use effective birth control during the study and for 8 months after treatment ends
      • Must provide signed informed consent to participate in the study
      • Must have valid social security coverage

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • History of allergic reactions to hydroxychloroquine or corticosteroids (medications used in the study)
  • Pregnancy or breastfeeding
  • Severe kidney disease (impaired kidney function)
  • Severe liver disease (impaired liver function)
  • Active infection requiring treatment
  • Heart rhythm problems or significant heart disease
  • Eye problems, particularly retinopathy (damage to the retina of the eye)
  • Uncontrolled diabetes
  • Current participation in other clinical trials
  • Mental conditions that may affect ability to provide informed consent
  • Use of medications that could interact with study drugs
  • Advanced lung disease requiring oxygen therapy
  • History of cancer in the past 5 years
  • Inability to perform required breathing tests
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Investigated drugs

  • Hydroxychloroquine

    is a medication commonly used to treat malaria and certain autoimmune conditions. In this trial, it is being studied as a treatment for pulmonary sarcoidosis (a condition affecting the lungs). It works by reducing inflammation and modifying the body's immune response.

  • Corticosteroids

    are anti-inflammatory medications that help reduce inflammation and suppress the immune system. In this trial, they are being tested at different doses in combination with hydroxychloroquine to treat pulmonary sarcoidosis. Corticosteroids are commonly used as a standard treatment for sarcoidosis to help improve breathing and reduce inflammation in the lungs.

What is already known about the treatment

  • Hydroxychloroquine

    An oral medication originally developed for malaria treatment that is now used in various autoimmune conditions and, as studied in this trial, for sarcoidosis. It works by reducing inflammation at the cellular level by interfering with the activity of immune cells and decreasing the production of inflammatory substances in the body. This antimalarial drug belongs to the disease-modifying antirheumatic drugs (DMARDs) class and is typically administered as tablets taken daily.

  • Corticosteroids

    A class of steroid medications that can be taken orally or administered through injection to reduce inflammation throughout the body. These drugs work by suppressing the immune system and reducing inflammatory responses, making them effective in treating various inflammatory conditions including sarcoidosis. Corticosteroids mimic the effects of hormones that your body naturally produces in the adrenal glands and are commonly prescribed in different doses (low to medium) depending on the severity of the condition and treatment requirements.

Investigated diseases

Sarcoidosis - A rare inflammatory disease that causes small clumps of cells called granulomas to form in various organs of the body. It most commonly affects the lungs and lymph nodes, but can also develop in the eyes, skin, heart, and other organs. The condition typically starts in the lungs, where the granulomas can cause inflammation and change the normal structure of the tissue. Sarcoidosis can develop gradually and may cause symptoms such as shortness of breath, persistent dry cough, fatigue, and chest pain. In some cases, the condition may not cause any noticeable symptoms and can be discovered accidentally during chest X-rays performed for other reasons. The disease can affect people of any age, but it most commonly develops between the ages of 20 and 40.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516101-23-00Protocol codeAPHP191105Estimated enrolment170 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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