Sarcoidosis Clinical Trial
— SARCORTOfficial title:
Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial
Verified date | January 2023 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
For pulmonary sarcoidosis, the initial dose recommended by the joint statement of the American Thoracic Society (ATS), European Respiratory Society (ERS), and The World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) is 20-40 mg per day.5 The exact dose and duration of treatment for sarcoidosis are unknown.4 We hypothesize that a higher dose of 40 mg per day as compared to a 20 mg/day dose of prednisone will be more effective in preventing post-treatment relapse by effective initial suppression of the granulomatous inflammation and reduction of the disease load. In this study, we compare the efficacy and safety of medium dose (40 mg/day prednisone) and low dose (20 mg/day prednisone) glucocorticoids in the treatment of acute sarcoidosis.
Status | Completed |
Enrollment | 86 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung/mediastinal lymph nodes 2. Diagnosis of sarcoidosis made on cytological or histological samples 3. 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 extrathoracic manifestation of the disease requiring treatment with low-medium dose glucocorticoids 4. Onset of symptoms within two years of study entry Exclusion Criteria: 1. Pregnant or lactating women 2. 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) 3. Having absolute contraindication for prednisone in a dose of 40 mg/day (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders) 4. Unwilling to participate in the study 5. Having received glucocorticoids (prednisolone equivalent >15 mg/day) for more than three weeks in the preceding two years |
Country | Name | City | State |
---|---|---|---|
India | Postgraduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse or treatment failure | The proportion of subjects with a relapse or treatment failure in the two study groups (initial dose 40 mg/day versus 20 mg/day of prednisone) at the end of 18 months | 18 months | |
Secondary | Mean time to relapse/treatment failure | The difference between the mean time to relapse/treatment failure in the study groups | 18 months | |
Secondary | Response | The proportion of subjects with worsening, stabilization, improvement or resolution of the disease in the study groups at the end of 18 months | 18 months | |
Secondary | Lung function early | The difference in the mean change in forced vital capacity between the study groups at the end of 6 months | 6 months | |
Secondary | Cumulative dose of prednisolone | The difference in the mean cumulative dose of prednisolone between the study groups at the end of 18 months | 18 months | |
Secondary | Adverse effects | The adverse effects of treatment (acne, weight gain, hyperglycemia, hypertension, adrenal insufficiency, osteoporosis and any other adverse effects related to prednisolone) between the study groups at the end of 18 months | 18 months | |
Secondary | Change in the sarcoidosis-related quality-of-life assessed by the score on the Sarcoidosis Health Questionnaire at treatment completion | The Sarcoidosis Health Questionnaire is a health-related quality-of-life questionnaire for patients with sarcoidosis. Higher scores reflect better quality-of-life | 6 months | |
Secondary | Change in the sarcoidosis-related quality-of-life assessed by the score on the Sarcoidosis Health Questionnaire at completion of follow-up | The Sarcoidosis Health Questionnaire is a health-related quality-of-life questionnaire for patients with sarcoidosis. Higher scores reflect better quality-of-life | 18 months | |
Secondary | Change in fatigue severity assessed by the score on the Fatigue Assessment Scale at treatment completion | The Fatigue Assessment Scale is a validated instrument for assessing sarcoidosis-related fatigue. Higher scores reflect more severe fatigue | 6 months | |
Secondary | Change in fatigue severity assessed by the score on the Fatigue Assessment Scale at completion of follow-up | The Fatigue Assessment Scale is a validated instrument for assessing sarcoidosis-related fatigue. Higher scores reflect more severe fatigue | 18 months | |
Secondary | Lung function late | The difference in the mean change in forced vital capacity between the study groups at the end of18 months | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04008069 -
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
|
Phase 2 | |
Recruiting |
NCT02807025 -
Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
|
N/A | |
Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Completed |
NCT00274352 -
A Study of Adalimumab to Treat Sarcoidosis of the Skin
|
Phase 2 | |
Completed |
NCT00373555 -
Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis
|
N/A | |
Completed |
NCT00326534 -
Rickettsial Genesis to Sarcoidosis in Denmark
|
N/A | |
Recruiting |
NCT00470327 -
A Study of the Natural Progression of Interstitial Lung Disease (ILD)
|
||
Completed |
NCT00512967 -
The Occurence of Inflammation and Oxidative Stress in Lung Diseases
|
N/A | |
Recruiting |
NCT01745237 -
Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
|
||
Completed |
NCT00369980 -
Diagnostic Usefulness of Fluorine–18-α–Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient
|
N/A | |
Completed |
NCT00379275 -
Eye and Immunogenetic Features of Sarcoidosis
|
N/A | |
Completed |
NCT00366509 -
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
|
||
Completed |
NCT06396910 -
TB and Sarcoidosis Granuloma
|
||
Completed |
NCT04156789 -
Obstructive Sleep Apnoea in Sarcoidosis
|
||
Recruiting |
NCT02916459 -
EBUS-TBNA vs Flex 19G EBUS-TBNA
|
N/A | |
Recruiting |
NCT02827734 -
Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
|
||
Completed |
NCT02546388 -
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
|
N/A | |
Completed |
NCT01687517 -
Efficacy and Safety of Influenza Vaccine During Sarcoidosis
|
Phase 3 | |
Completed |
NCT01139710 -
Sarcoidosis-associated Pulmonary Hypertension
|
N/A | |
Terminated |
NCT00747461 -
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
|
Phase 4 |