Comparing 12 and 6 months of prednisolone for lung sarcoidosis
Compares longer and shorter prednisolone courses in adults with lung sarcoidosis.
Plain-language title generated from the registry record
Registry title: Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis
Key facts
- Where
- Chandigarh, IndiaSee the site
- Phase
- Phase 4
Where in India
- Post Graduate Institute of Medical Education and ResearchChandigarh, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Trial code
- NCT06654934
- Record updated
- 23 October 2024
- Original description
In this study, the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone will be compared. The hypothesis is that longer treatment DURAtion would be more effective in preventing treatment failure or early relapse in SARCoidosis (DURASARC trial). The premise of this hypothesis is that even small doses of prednisolone given over longer periods can effectively suppress disease activity in sarcoidosis without a significant increase in adverse effects.Read full original descriptionShow less
Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis: a Randomized Trial
In this study, the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone will be compared. The hypothesis is that longer treatment DURAtion would be more effective in preventing treatment failure or early relapse in SARCoidosis (DURASARC trial). The premise of this hypothesis is that even small doses of prednisolone given over longer periods can effectively suppress disease activity in sarcoidosis without a significant increase in adverse effects.
Inclusion: 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: Having received glucocorticoids (prednisolone equivalent >15 mg/day) for more than three weeks in the preceding year; 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); Pregnant or lactating women; Unwilling to participate in the study.