Status:
COMPLETED
Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Glucocorticoids are the cornerstone of treatment of sarcoidosis and are used as the first-line agents in patients requiring immunosuppressive therapy.4 The optimal dose and duration of glucocorticoids...
Eligibility Criteria
Inclusion
- 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 extrathoracic manifestation of the disease requiring treatment with low-medium dose glucocorticoids
- Onset of symptoms within two years of study entry
Exclusion
- 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 in a dose of 40 mg/day (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 two years
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03265405
Start Date
April 1 2017
End Date
October 31 2022
Last Update
January 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012