Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis

NCT03265405 | Completed Phase 4

• 1 other identifier: INT/IEC/2017/299
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Keywords

pulmonary sarcoidosis; corticosteroids; glucocorticoids; relapse; interstitial lung disease; diffuse parenchymal lung disease; immunosuppression; mediastinal lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mean time to relapse/treatment failure

  18 months

• Response

  18 months

• Lung function early

  6 months

• Cumulative dose of prednisolone

  18 months

• Adverse effects

  18 months

Study Arms (2)

Low dose prednisolone

ACTIVE COMPARATOR

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 tapered over 2 weeks and discontinued.

Drug: Low dose prednisolone

Medium dose prednisolone

ACTIVE COMPARATOR

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 tapered over 2 weeks and discontinued.

Drug: Medium dose prednisolone

Interventions

Low dose prednisolone DRUG

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 tapered over 2 weeks and discontinued.

Low dose prednisolone

Medium dose prednisolone DRUG

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 tapered over 2 weeks and discontinued.

Medium dose prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

• Dhooria S, Sehgal IS, Agarwal R, Muthu V, Prasad KT, Dogra P, Debi U, Garg M, Bal A, Gupta N, Aggarwal AN. High-dose (40 mg) versus low-dose (20 mg) prednisolone for treating sarcoidosis: a randomised trial (SARCORT trial). Eur Respir J. 2023 Sep 9;62(3):2300198. doi: 10.1183/13993003.00198-2023. Print 2023 Sep.

  PMID: 37690784 DERIVED

MeSH Terms

Conditions

Sarcoidosis; Sarcoidosis, Pulmonary; Recurrence; Lung Diseases, Interstitial

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 29, 2017
• Study Start: April 1, 2017
• Primary Completion: October 7, 2022
• Study Completion: October 31, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

IN (1)