Targeting Oxidative Stress in Chronic Beryllium Disease

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to understand if a drug called mesalamine helps to control inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive effects of prednisone, and thus reduce the immune response to beryllium.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Diagnosis of chronic beryllium disease based on the criteria below:

1. History of beryllium exposure, and;

2. Positive blood and/or bronchoalveolar lavage Beryllium Lymphocyte Proliferation Tests (BeLPT), and;

3. Biopsy-proven pathologic changes consistent with CBD-non-caseating granulomas and/or mononuclear cell interstitial infiltrates, and;

4. Positive bronchoalveolar lavage (BAL) BeLPT and > 15% lymphocytes in BAL fluid.

Exclusion Criteria:

• History of Hepatic disease

• History of Renal disease

• Hypersensitivity to Pentasa (5-ASA) or salicylates.

• Pregnancy

• Presence of another disease that may be expected to significantly affect patient mortality (e.g., HIV), severe cor pulmonale);

• The use of blood thinners.

• Current use of tobacco (smoking or otherwise) in the past 6 months

• Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures (if undergoing bronchoscopy) that form part of the inclusion/exclusion criteria or part of the outcome measure.

If undergoing bronchoscopy:

• Severe room air hypoxemia (precluding transbronchial lung biopsy and/or BAL), e.g., pO2 < 45 (Denver altitude 5,280 feet);