Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis

NCT06654934 | Not Yet Recruiting Phase 4

• 1 other identifier: Pulm-962
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Keywords

granulomatous disease; interstitial lung disease; diffuse lung disease; tuberculosis; steroid; ILD

Outcome Measures

Primary Outcomes (1)

• Relapse or treatment failure

  Proportion of subjects with a relapse (worsening after 4 weeks of stopping treatment) or treatment failure (worsening during treatment or within 4 weeks of stopping treatment requiring an increase in the treatment intensity) in the study groups. Worsening is defined as persistent (≥2 weeks) worsening of cough and/or dyspnea, and one or more of the following: a) worsening of lung function (≥5-point reduction in percentage-predicted FVC or FEV1), or b) increase in the chest radiograph abnormalities due to sarcoidosis.

  12 months

Secondary Outcomes (6)

• Treatment response

  12 months

• Sarcoidosis health related quality of life

  12 months

• Forced vital capacity

  12 months

• Adverse effects

  12 months

• Time to relapse or treatment failure

  12 months

Study Arms (2)

Short duration

ACTIVE COMPARATOR

6-month prednisolone (shorter treatment)

Drug: Prednisolone

Long duration

ACTIVE COMPARATOR

12-month prednisolone (longer treatment)

Drug: Prednisolone

Interventions

Prednisolone DRUG

An initial dose of 40 mg/day will be administered for 1 week, followed by 30 mg/day for 1 week, 20 mg/day for 6 weeks, 15 mg/day for 4 weeks, 10 mg/day for 8 weeks, 5 mg/day for 4 weeks, 2.5 mg/day for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 2485 mg).

Short duration

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years
• 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 extrapulmonary 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 (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 year

Sponsors & Collaborators

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

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Sarcoidosis; Lung Diseases, Interstitial; Tuberculosis

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Sahajal Dhooria, MD, DM

CONTACT

+917087002015; sahajal@gmail.com

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: Associate Professor

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Anticipated: 31-Dec-2026 till indefinite

Locations

IN (1)