Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis

NCT06654934 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Phase 4

Started

2024-11

Last updated

2024-10-23

Condition(s) studied

Sarcoidosis

Investigational drug(s) / intervention(s)

Prednisolone →Prednisolone →

Prednisolone: An initial dose of 40 mg/day will be administered for 1 week, followed by 30 mg/day for 1 week, 20 mg/day for 6 weeks, 15 mg/day for 4 weeks, 10 mg/day for 8 weeks, 5 mg/day for 4 weeks, 2.5 mg/day for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 2485 mg).

Prednisolone: An initial dose of 40 mg/day will be administered for 1 week, followed by 30 mg/day for 1 week, 20 mg/day for 6 weeks, 15 mg/day for 4 weeks, 10 mg/day for 14 weeks, 5 mg/day for 24 weeks, 2.5 mg/day for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 3605 mg).

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Relapse or treatment failure — 12 months
Proportion of subjects with a relapse (worsening after 4 weeks of stopping treatment) or treatment failure (worsening during treatment or within 4 weeks of stopping treatment requiring an increase in the treatment intensity) in the study groups. Worsening is defined as persistent (≥2 weeks) worsening of cough and/or dyspnea, and one or more of the following: a) worsening of lung function (≥5-point reduction in percentage-predicted FVC or FEV1), or b) increase in the chest radiograph abnormalities due to sarcoidosis.

Trial sites (1)

Facility	City	Region	Status
Post Graduate Institute of Medical Education and Research	Chandigarh	Chandigarh