Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis

NCT ID: NCT06654934

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-12-31

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.

Conditions

Sarcoidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short duration

6-month prednisolone (shorter treatment)

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

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).

Long duration

12-month prednisolone (longer treatment)

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Sahajal Dhooria

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Countries

India

Central Contacts

Sahajal Dhooria, MD, DM

Role: CONTACT

sahajal@gmail.com

+917087002015

Facility Contacts

Sahajal Dhooria, MD, DM

Role: primary

sahajal@gmail.com

+917087002015

Other Identifiers

Pulm-962

Identifier Type: -

Identifier Source: org_study_id