Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 5:14 PM
Study NCT ID:
NCT06654934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis
Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Organization:
Study Overview
Official Title:
Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis: a Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DURASARC
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: