Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis

ConditionSarcoidosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Prednisolone
  • Prednisolone

Treatment groups

100 Participants
are divided into 2 treatment groups