Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial, called the DURASARC trial, is investigating how effective and safe it is to treat pulmonary sarcoidosis with prednisolone for either 6 months or 12 months. Sarcoidosis is a condition where small clusters of inflammatory cells can form in different parts of the body, often the lungs, leading to symptoms like difficulty breathing. The researchers believe that extending the treatment to 12 months might help prevent patients from experiencing a relapse or treatment failure, even if the doses of medication are low.

To participate in this study, individuals need to be between 18 and 65 years old and have a confirmed diagnosis of sarcoidosis affecting the lungs. They should also be experiencing significant symptoms or have reduced lung function that requires treatment. However, pregnant or breastfeeding women, and those with certain serious health conditions that need high doses of steroids, cannot join. Those who qualify will be part of a careful evaluation to determine how well the different treatment durations work, while also monitoring side effects. The trial is not yet recruiting participants, but it aims to provide valuable insights into managing this condition more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 65 years
• • Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung/mediastinal lymph nodes
• • Diagnosis of sarcoidosis made on cytological or histological samples
• • Having significant symptoms requiring immunosuppressive treatment and/or having reduced lung function (defined as forced vital capacity or forced expiratory volume in one second (FEV1) less than 80% predicted) or an extrapulmonary manifestation of the disease requiring treatment with low-medium dose glucocorticoids
• • Onset of symptoms within two years of study entry
• Exclusion Criteria:
• • Pregnant or lactating women
• • Subjects having any manifestation requiring high dose steroid treatment (this includes symptomatic neurosarcoidosis, life threatening cardiac sarcoidosis, vision threatening posterior uveitis or other forms of vision threatening ocular sarcoidosis)
• • Having absolute contraindication for prednisone (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders)
• • Unwilling to participate in the study
• • Having received glucocorticoids (prednisolone equivalent \>15 mg/day) for more than three weeks in the preceding year