Phase 2
N=18
Targeting Oxidative Stress in Chronic Beryllium Disease
Chronic Beryllium Disease
Bottom Line
View on ClinicalTrials.gov: NCT01088243 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 — 48.61; 9.33; 22.07; 3.8 Stimulation index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mesalamine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Jewish Health
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 |
48.61; 9.33; 22.07; 3.8 | — |
| SECONDARY Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa) |
62; -1750 | — |
| SECONDARY Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6 |
4.93; 10.38 | — |
| SECONDARY HDAC2 Levels |
— | — |
| SECONDARY Glucocorticoid Receptors |
— | — |
| SECONDARY Lung Function |
2.2; -0.91; 1.6; -0.08; 2.4; -0.16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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);
Data sourced from ClinicalTrials.gov (NCT01088243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.