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Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis (SARCORT)

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ClinicalTrials.gov Identifier: NCT03265405
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Sahajal Dhooria, Postgraduate Institute of Medical Education and Research

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 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.

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Low dose prednisolone Drug: Medium dose prednisolone Phase 4

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 is an unresolved issue. For pulmonary sarcoidosis, the initial dose recommended by the joint statement of the ATS/ERS/WASOG is 20-40 mg per day.5 The duration of treatment recommended is at least one year. However, mild disease of recent onset may respond to a shorter duration of treatment. Further, as most of the toxic effects of glucocorticoids are cumulative, the dose and duration of steroids need to be kept to a minimum to balance the benefit and risks of treatment.

Two large studies performed about two decades ago used an initial dose of 30 mg and 20 mg respectively for treating acute sarcoidosis. While the British Thoracic Society employed steroid treatment (initial dose 30 mg/day) for one year, in the Finnish study, oral glucocorticoids (initial dose 20 mg/day) were administered for three months and were followed by inhaled budesonide.3,6 In a recent Delphi study of experts, 37% and 20% of the experts used an initial prednisone equivalent dose of 40 mg per day and 20 mg per day regardless of weight, respectively.7 About 23% used doses of 20 mg, 30 mg, or 40 mg per day depending on weight. However, consensus was reached that a dose higher than 40 mg per day is not required. Apart from the initial response to glucocorticoids in symptoms and lung function, the rate of relapse after cessation of treatment is an important outcome in the management of sarcoidosis.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis Steroids

Arm Intervention/treatment
Active Comparator: Low dose prednisolone
An initial dose of 20 mg/day will be administered for 8 weeks, followed by 15 mg/day for 8 weeks, 10 mg/day for 4 weeks, and 5 mg/day for 4 weeks, after which the drug will be discontinued.
Drug: Low dose prednisolone
An initial dose of 20 mg/day will be administered for 8 weeks, followed by 15 mg/day for 8 weeks, 10 mg/day for 4 weeks, and 5 mg/day for 4 weeks, after which the drug will be discontinued.

Active Comparator: Medium dose prednisolone
An initial dose of 40 mg/day will be administered for 4 weeks, followed by 30 mg/day for 4 weeks, 20 mg/day for 4 weeks, 15 mg/day for 4 weeks, 10 mg/day for 4 weeks, and 5 mg/day for 4 weeks, after which the drug will be discontinued.
Drug: Medium dose prednisolone
An initial dose of 40 mg/day will be administered for 4 weeks, followed by 30 mg/day for 4 weeks, 20 mg/day for 4 weeks, 15 mg/day for 4 weeks, 10 mg/day for 4 weeks, and 5 mg/day for 4 weeks, after which the drug will be discontinued.

No Intervention: Observation
The subjects with sarcoidosis who do not have any indication for immunosuppressive treatment will be observed and monitored. If any treatment requiring indication arises during the observed period, the subjects will be randomized to one of the above study groups



Primary Outcome Measures :
  1. Relapse or treatment failure [ Time Frame: 18 months ]
    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


Secondary Outcome Measures :
  1. Mean time to relapse/treatment failure [ Time Frame: 18 months ]
    The difference between the mean time to relapse/treatment failure in the study groups

  2. Response [ Time Frame: 18 months ]
    The proportion of subjects with stabilization, improvement or resolution of the disease in the study groups at the end of 18 months

  3. Lung function early [ Time Frame: 6 months ]
    The difference in the mean change in forced vital capacity between the study groups at the end of 6 months

  4. Cumulative dose of prednisolone [ Time Frame: 18 months ]
    The difference in the mean cumulative dose of prednisolone between the study groups at the end of 18 months

  5. Adverse effects [ Time Frame: 18 months ]
    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

  6. Prednisolone dose between relapse and no relapse groups [ Time Frame: 18 months ]
    The difference in mean cumulative dose of prednisolone per kilogram body weight (at baseline) between patients with and without relapse or treatment failure

  7. Sarcoidosis health and fatigue [ Time Frame: 18 months ]
    The difference in the change in the fatigue assessment scale and the Sarcoidosis Health Questionnaire respectively.

  8. Lung function late [ Time Frame: 18 months ]
    The difference in the mean change in forced vital capacity between the study groups at the end of18 months

  9. Predictors of relapse/treatment failure [ Time Frame: 18 months ]
    Predictors of relapse or treatment failure will be assessed by a multivariate analysis taking the group allocation as the dependent variable and adjusting for age, gender, disease stage, baseline lung function, ACE levels

  10. Observation group crossover to treatment group [ Time Frame: 18 months ]
    Difference in the proportion of subjects in the observation group requiring corticosteroid treatment during follow up

  11. Predictors of development of treatment-requiring indication in the observation (no intervention) group [ Time Frame: 18 months ]
    A multivariate analysis will be performed to assess the factors that predict the development of an indication for immunosuppressive treatment in the group that would receive no intervention. It will include factors such as age, gender, disease stage, baseline lung function, baseline symptoms and their severity, baseline ACE levels



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265405


Contacts
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Contact: Sahajal Dhooria, MD, DM +919530661388 sahajal@gmail.com
Contact: Ritesh Agarwal, MD, DM, FCCP +919478402976 agarwal.ritesh@outlook.in

Locations
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India
Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Digambar Behera, MD    9815705357    dirlrsi@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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Responsible Party: Sahajal Dhooria, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03265405    
Other Study ID Numbers: INT/IEC/2017/299
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sahajal Dhooria, Postgraduate Institute of Medical Education and Research:
pulmonary sarcoidosis
corticosteroids
glucocorticoids
relapse
interstitial lung disease
diffuse parenchymal lung disease
immunosuppression
mediastinal lymphadenopathy
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents