Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis
Sarcoidosis; Antimycobacterial Therapy;
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial|
- 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 ] [ Designated as safety issue: No ]
- Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
- Change in 6 minute walk distance, oxygen saturation and level of dyspnea [ Time Frame: Baseline, 4, 8 and 16 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- Change in FEV1 [ Time Frame: Baseline, 4, 8, 16 and 24 weeks ] [ Designated as safety issue: No ]
- Failure of standard Therapy [ Time Frame: Baseline, 4, 8, and 16 weeks ] [ Designated as safety issue: No ]We will assess how many subjects in either arm need escalation of their standard regimen (ie increase in prednisone) during the 16 weeks.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Other Name: LevaquinDrug: Ethambutol Drug: Azithromycin
Other Name: Z-packDrug: Rifampin
Other Name: Rifadin, Rimactane
Placebo Comparator: Placebo
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02024555
|Contact: Wonder Drake, MDfirstname.lastname@example.org|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator: Robert Baughman, MD|
|Cleveland, Ohio, United States, 44195|
|Contact: Dan Culver, DO|
|Principal Investigator: Dan Culver, DO|
|United States, Tennessee|
|Vanderbilt University School of Medicine||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Wonder Drake, MD 615-322-2035 email@example.com|
|Principal Investigator: Wonder Drake, MD|
|Vanderbilt University Medical Cener||Recruiting|
|Nashville, Tennessee, United States|
|Contact: Wonder Drake 615-322-2035 firstname.lastname@example.org|
|Principal Investigator:||Wonder Drake, MD||Vanderbilt University School of Medicine|