Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654934
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis
Sponsor:
None
Organization:
None
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:
No
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 prednisoneprednisolone 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 mgday 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None