Targeting Oxidative Stress in Chronic Beryllium Disease
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Chronic Beryllium Disease
In brief
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.
Key facts
- Study ID
- NCT01088243
- Run by
- National Jewish Health
- People needed
- 18
- Starts
- 2010-03-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2018-10-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of chronic beryllium disease based on the criteria below:
- History of beryllium exposure, and;
- Positive blood and/or bronchoalveolar lavage Beryllium Lymphocyte Proliferation Tests (BeLPT), and;
- Biopsy-proven pathologic changes consistent with CBD-non-caseating granulomas and/or mononuclear cell interstitial infiltrates, and;
- Positive bronchoalveolar lavage (BAL) BeLPT and > 15% lymphocytes in BAL fluid.
You may not qualify if…
- 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);
Where it is running
- National Jewish Health — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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