Clinical trial NCT06654934: Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis
Official title: Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sarcoidosis
Keywords: granulomatous disease
interstitial lung disease
diffuse lung disease
tuberculosis
steroid
ILD
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Sarcoidosis is an idiopathic disorder that manifests with granulomatous inflammation affecting several organs, but most commonly the lungs and mediastinal lymph nodes. When asymptomatic or minimally symptomatic, it does not require regular pharmacologic treatment. Organ dysfunction or impaired quality of life trigger the introduction of immunosuppressive therapy. Glucocorticoids are the first-line drugs for this purpose. Different glucocorticoids have been studied in the past, but prednisone/prednisolone is the most used agent. Evidence is sparse on the ideal glucocorticoid regimen to treat patients with sarcoidosis. A recent randomized controlled trial (RCT) named the SARCORT study found that a 6-month prednisolone regimen using an initial dose of 40 mg/day was not superior to one that initiated with a daily dose of 20 mg. The appropriate duration of glucocorticoid treatment for treating newly diagnosed patients with sarcoidosis is unknown.

The treatment duration of 6 months in the SARCORT study was at the shorter end of the suggested range (6-24 months). There was a high (45%) overall relapse incidence which was proposed to be due to the shorter duration of treatment. In contrast, a study with a glucocorticoid treatment duration of one year described a 13% relapse rate. In another study, significantly better results were observed in patients who had received prolonged treatment for 4 years or more.

In this study, the aim is to compare the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone. 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: 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 outcomes:
measure: Relapse or treatment failure
timeFrame: 12 months
Secondary outcomes:
measure: Treatment response
timeFrame: 12 months
measure: Sarcoidosis health related quality of life
timeFrame: 12 months
measure: Forced vital capacity
timeFrame: 12 months
measure: Adverse effects
timeFrame: 12 months
measure: Time to relapse or treatment failure
timeFrame: 12 months
measure: Sarcoidosis-associated fatigue
timeFrame: 12 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References: