Study on Methotrexate and Prednisone for Treating Lung Sarcoidosis in Patients

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What is this study about?

This clinical trial is focused on studying the effectiveness of two medications, methotrexate and prednisone, as treatments for pulmonary sarcoidosis. Pulmonary sarcoidosis is a condition where small clusters of inflammatory cells, called granulomas, form in the lungs, which can affect breathing. The purpose of the study is to compare how well these two medications work as the first treatment option for this condition.

Participants in the study will be randomly assigned to receive either methotrexate or prednisone. Methotrexate is a medication that works by interfering with the growth of certain cells, while prednisone is a type of corticosteroid that helps reduce inflammation in the body. Both medications will be taken in tablet form by mouth. The study will last for a period of 24 weeks, during which the effects of the medications on lung function and overall health will be monitored.

Throughout the study, participants will have regular check-ups to assess their lung function and monitor any changes. The main focus will be on measuring the change in lung capacity, specifically the forced vital capacity, which is a measure of how much air a person can exhale after taking a deep breath. Additionally, other health markers, known as biomarkers, will be evaluated to provide further insights into the effectiveness and tolerability of the treatments.

1 joining the trial

Upon joining the trial, the patient is confirmed to have a diagnosis of pulmonary sarcoidosis based on specific criteria.

The patient must be at least 18 years old and have a pulmonary indication for treatment with specific lung function test results.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s lung function, including a test called Forced Vital Capacity (FVC) and a diffusion capacity test for carbon monoxide.

These tests help determine the baseline lung function before starting the treatment.

3 treatment phase

The patient is randomly assigned to receive either methotrexate or prednisone as the first-line therapy.

Both medications are administered orally. The specific dosage and frequency are determined by the trial protocol.

4 ongoing monitoring

Throughout the trial, the patient’s lung function is regularly monitored to assess any changes in the Forced Vital Capacity.

Additional tests may include the measurement of biomarkers to evaluate the treatment’s effectiveness and tolerability.

5 completion of trial

The trial is expected to conclude by March 1, 2025.

Upon completion, the final results will be analyzed to determine the effectiveness of methotrexate compared to prednisone in treating pulmonary sarcoidosis.

Who Can Join the Study?

  • The patient must have a diagnosis of sarcoidosis. This is a condition that affects the lungs and can be confirmed by specific medical criteria or by a team of experts based on clinical and imaging findings.
  • The patient must be 18 years or older.
  • The patient must have a lung-related reason for treatment, with lung tissue involvement shown on an X-ray or CT scan done within the last three months, as determined by the doctor following current guidelines.
  • The patient must have specific lung function test results: a forced vital capacity (FVC), which measures how much air you can exhale, of 90% or less of what is expected; or a diffusion capacity of the lung for carbon monoxide (DLCO), which measures how well your lungs transfer gas, of 70% or less of what is expected; or a decline of 5% or more in FVC or 10% or more in DLCO in the past year. These tests use standard reference values.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands
Stichting OLVG Amsterdam The Netherlands

Other Sites

Site Name City Country Status
Isala Klinieken Stichting Zwolle The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Jeroen Bosch Hospital s-Hertogenbosch The Netherlands
Vaahp Uugztrmljdqa Amsterdam The Netherlands
Rflwxyyvi Zsgtqxspyc Seqghbyff Arnhem The Netherlands
Sbyroepyg Mksfbho Zqsibvllvm Groningen The Netherlands
Edzqhxm Ubrmsdarujdp Mztsqhi Cgidthw Rrbfzgnwh (htzdism Mvi Rotterdam The Netherlands
Azrgrpgrh Uap Amsterdam The Netherlands
Lsbsf Uafwsyjmblxg Mdccgcq Cerczld (ljqlm Leiden The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.01.2020

Trial locations

Investigated drugs:

Methotrexate is being studied as a first-line treatment for pulmonary sarcoidosis. It is a medication that can help reduce inflammation and suppress the immune system, which may be beneficial in managing the symptoms of sarcoidosis.

Prednisone is also being evaluated as a first-line treatment for pulmonary sarcoidosis. It is a type of corticosteroid that works by reducing inflammation in the body, which can help alleviate symptoms associated with sarcoidosis.

Investigated diseases:

Pulmonary sarcoidosis – Pulmonary sarcoidosis is a condition characterized by the growth of tiny clusters of inflammatory cells, called granulomas, in the lungs. These granulomas can cause the lung tissue to become inflamed and may lead to scarring over time. The disease often begins with symptoms such as a persistent cough, shortness of breath, and chest pain. As it progresses, it can affect lung function, leading to decreased ability to breathe deeply or efficiently. The exact cause of pulmonary sarcoidosis is unknown, but it is believed to involve an abnormal immune response. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more significant respiratory challenges.

Trial ID:
2024-514055-15-00
Protocol code:
NL71782.078.19
Trial Phase:
Therapeutic confirmatory (Phase III)

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