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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
Albany Medical Center
Albany, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
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.
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. This will involve comparing sarcoidosis and placebo after 16 weeks of therapy.
Time frame: Baseline to 16 weeks
Radiographic Improvement in Sarcoidosis Lung Disease by Frontal Chest X-ray .
Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . Local investigators will score chest x-rays.
Time frame: Baseline and 16 weeks
Six Minute Walk, Distance in Meters
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time frame: Baseline, 4, 8, and 16 and 24 weeks
Change in Oxygen Saturation
measured using pulse oximetry
Time frame: Baseline, 4, 8, and 16 and 24 weeks
Change in Level of Dyspnea
Outcome measure if a composite
Time frame: Baseline, 4, 8 and 16 weeks
Change in the Saint George's Respiratory Questionnaire (SGRQ)
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.
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This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Time frame: Baseline and 16 weeks
Fatigue Assessment Scale (FAS).
The FAS is a 10-item general fatigue questionnaire to assess fatigue. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Time frame: Baseline, 4, 8, 16 and 24 weeks
Change in the King's Sarcoidosis Questionnaire (KSQ) for the Assessment of Health Status;
The KSQ is a free, online questionnaire to be filled out by sarcoidosis patients. The questionnaire takes around 10 minutes and is split into 5 sections; general health status, lungs, medication, skin and eyes. There are 29 questions in total, however some questions may not be answered (depending on the type of sarcoidosis affected). Each question asks patients to rate how they feel about many different aspects of their life, for instance how much pain they are in or how difficult they find everyday tasks. Information provided is confidential. Results are given as a number between 1-100 with higher numbers indicating better health.
Time frame: Baseline and 16 weeks
Adverse Events
Safety profile of regimen as evidenced by the number of adverse events
Time frame: 24 weeks
FEV1%
FEV1% was measure pre and post 6 minute walk test
Time frame: Baseline, 4, 8, and 16 and 24 weeks
Failure of Standard Therapy
We will assess how many subjects in either arm need escalation of their standard regimen (ie increase in prednisone) during the 16 weeks.
Time frame: Baseline to 16 weeks
Abnormal Lab Values
Safety profile of regimen as evidenced by the number of abnormal lab values classified as Adverse Events
Time frame: baseline to 16 weeks