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

3 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Groupe Hospitalier Du Sud Ile De France Melun France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Ctre Hospitalier Intercomm R Ballanger Aulnays-Sous-Bois France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier De Saint-Denis St Denis France
Ctqdzi Hbdmksihwro Eiglxpotuc Evreux France
Gbsflwvtch Hadwoqqloif Eheokmmf Mqqompljccj Seapqa Vcbq Eaubonne France
Cqeeen Hseltghtqje Iyqyuivkymhsd Lg Rvgjbwpooxykncrha Monfermeil France
Csyafk Hxgpmlvygxn Uyxpaktekuopu Dq Dcjpj Dijon France
Aphtimsshd Ppqycpat Hwhhqizb Dl Mqnsuctbs Marseille France
Cxacul Hkpsxqlglwt Rswjdnbg Ujnkqqmitpzof Dn Tvebb Tours France
Gwnywn Hdoukmitqml Umifkbcimpgmq Pzjgw Puihnubvtek Et Nhzgvxkbainj Paris France
Cwopaq Hxtxqvoriwf Rkylealf Deqcoxxjnckcsi Angers France
Hkxckipl Usqmvbctxjlmqe Ssuuooiylh &eftvcw Hvyuzsp dv Hieiichpbxl STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
30.06.2022

Trial locations

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.

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 ID:
2024-516101-23-00
Protocol code:
APHP191105
NCT ID:
NCT05247554
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis

    Recruiting

    2 1
    Denmark France Germany Greece The Netherlands Norway
  • Study on Methotrexate and Prednisone for Treating Lung Sarcoidosis in Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands