Clinical Trial: Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial

Brief Summary: The primary purpose of this study is to investigate the efficacy and safety of oral antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants.

Detailed Summary:

Primary Objective: To assess the efficacy and safety of oral CLEAR therapy in patients with confirmed progressive pulmonary sarcoidosis.

Hypothesis: The CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants by augmenting T cell responses through the normalization of p56Lck expression and IL-2 production.


Sponsor: Vanderbilt University

Current Primary Outcome: Determine the effect of CLEAR therapy versus placebo on the change in percent predicted absolute forced vital capacity (FVC) in participants with pulmonary sarcoidosis, comparing baseline with performance after completion of 16 weeks of therapy. [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . [ Time Frame: Baseline and 16 weeks ]
  • Change in 6 minute walk distance, oxygen saturation and level of dyspnea [ Time Frame: Baseline, 4, 8 and 16 weeks ]
    Outcome measure if a composite
  • Change in the Saint George's Respiratory Questionnaire (SGRQ; King's Sarcoidosis Questionnaire (KSQ) for the assessment of health status; The Fatigue Assessment Scale (FAS). [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]
    Outcome measure if a composite
  • Safety profile of regimen as evidenced by adverse events and abnormal lab values, tolerability and toxicity of the treatment regimen including comparison of reported adverse events and abnormal laboratory values compared to placebo. [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]
  • Change in FEV1 [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]
  • Failure of standard Therapy [ Time Frame: Baseline, 4, 8, and 16 weeks ]
    We will assess how many subjects in either arm need escalation of their standard regimen (ie increase in prednisone) during the 16 weeks.


Original Secondary Outcome:

  • Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . [ Time Frame: Baseline and 16 weeks ]
  • Change in 6 minute walk distance, oxygen saturation and level of dyspnea [ Time Frame: Baseline, 4, 8 and 16 weeks ]
  • Change in the Saint George's Respiratory Questionnaire (SGRQ; King's Sarcoidosis Questionnaire (KSQ) for the assessment of health status; The Fatigue Assessment Scale (FAS). [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]
  • Safety profile of regimen as evidenced by adverse events and abnormal lab values, tolerability and toxicity of the treatment regimen including comparison of reported adverse events and abnormal laboratory values compared to placebo. [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]
  • Change in FEV1 [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ]
  • Failure of standard Therapy [ Time Frame: Baseline, 4, 8, and 16 weeks ]
    We will assess how many subjects in either arm need escalation of their standard regimen (ie increase in prednisone) during the 16 weeks.


Information By: Vanderbilt University

Dates:
Date Received: December 26, 2013
Date Started: March 2014
Date Completion: May 2017
Last Updated: August 10, 2016
Last Verified: August 2016