Efficacy of Antituberculous Therapy in Management of Sarcoidosis

NCT01245036 | Completed DMC

• 1 other identifier: Sarc/Att/01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

From the time sarcoidosis has been described, there has always been a belief that the disease is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT) is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but the results of these trials have been discouraging. These trials were generally small studies and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and streptomycin. In our experience nearly one third of patients who are finally diagnosed to have sarcoidosis, have received ATT for variable length of time, but its impact of final outcome of sarcoidosis has not been studied. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.

Conditions

Sarcoidosis; Tuberculosis

Keywords

Sarcoidosis; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Remission rates

  Three months

Secondary Outcomes (2)

• Relapse rates in the two groups

  six and 12 months after completion of treatment

• Treatment related adverse effects in the two groups.

  Through out

Study Arms (1)

Glucocorticoid arm

ACTIVE COMPARATOR

Prednisolone 0.75 mg/kg/day for 6 weeks (maximum 60 mg) Prednisolone 0.5 mg/kg/day for 6 weeks (maximum 40 mg) Prednisolone 0.25 mg/kg/day for 6 months (maximum 20 mg) Taper over the next three months Prednisolone 0.25 mg/kg EOD for 15 days Prednisolone 0.125 mg/kg EOD for 15 days Then taper by 5 mg every 15 days to complete one year

Drug: Antituberculous therapy along with steroids

Interventions

Antituberculous therapy along with steroids DRUG

INH (300 mg/day) plus Rifampicin (450 mg/day if wt.\<50 kg and 600 mg/day if wt. \>50 kg) for six months Prednisolone 1 mg/kg/day for 6 weeks (maximum 80 mg) Prednisolone 0.75 mg/kg/day for 6 weeks (maximum 60 mg) Prednisolone 0.5 mg/kg/day for 3 months (maximum 40 mg) Prednisolone 0.25 mg/kg/day for 3 months (maximum 20 mg) Taper over the next three months Prednisolone 0.25 mg/kg EOD for 15 days Prednisolone 0.125 mg/kg EOD for 15 days Then taper by 5 mg every 15 days to complete one year

Glucocorticoid arm

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed sarcoidosis defined by presence of all of the following criteria:
• Presence with clinical features of pulmonary (dyspnea, dry cough, chest pain, fever, fatigue or crackles) or extra pulmonary organ (lymph nodes, liver, spleen, skin, eyes, heart, etc.) involvement and consistent radiological involvement and
• Compact non-caseating granulomas on trans-bronchial biopsy which are tissue AFB smear-negative

You may not qualify if:

• Patients who have received glucocorticoid treatment before initial evaluation by us, or with presence of concomitant other cardio pulmonary disease will be excluded.

Sponsors & Collaborators

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

Study Sites (1)

Deaprtment of Pulmonary Medicine, PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Sarcoidosis; Tuberculosis

Interventions

Steroids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dheeraj Gupta

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: November 15, 2010
• First Posted: November 22, 2010
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

IN (1)