Clinical Trial: Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis

Brief Summary: Sarcoidosis is a granulomatous disease for which the molecular and immunologic association with mycobacteria continues to strengthen. The investigators are interested in conducting a proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are given antimycobacterial therapy, in addition to their standard therapy.

Detailed Summary:
Sponsor: Vanderbilt University

Current Primary Outcome: Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy. [ Time Frame: 8 weeks ]

The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.


Original Primary Outcome: To assess the efficacy and safety of antimycobacterial therapy in patients with pulmonary sarcoidosis. [ Time Frame: 1 year ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vanderbilt University

Dates:
Date Received: July 22, 2010
Date Started: July 2010
Date Completion:
Last Updated: October 26, 2012
Last Verified: October 2012