Targeting Oxidative Stress in Chronic Beryllium Disease
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ClinicalTrials.gov Identifier: NCT01088243 |
Recruitment Status
:
Completed
First Posted
: March 17, 2010
Results First Posted
: December 12, 2017
Last Update Posted
: January 10, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chronic Beryllium Disease | Drug: Mesalamine Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Targeting Oxidative Stress in Chronic Beryllium Disease |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Mesalamine
Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.
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Drug: Mesalamine
Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.
Other Names:
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Placebo Comparator: Placebo
Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.
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Drug: Placebo
Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.
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- Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 [ Time Frame: baseline and week 6 ]Primary endpoints are beryllium proliferation responses (BeLPT) in PBMCs (peripheral blood mononuclear cells) and BAL (bronchoalveolar lavage) cells. The BeLPT is a blood test that measures the immune response to beryllium exposure. If immune cells multiply in response to beryllium, this is considered an abnormal test results. If immune cells do not multiple, this is considered a normal test results. Results are reported as "stimulation index", which is a ratio of the number of cells grown with beryllium compared to the number of cells grown without beryllium. A value of 2.5 or less is considered normal, and a value greater than 2.5 is abnormal.
- Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa) [ Time Frame: baseline and week 6 ]Secondary outcomes include changes in bronchoalveolar lavage (BAL) tumor necrosis factor alpha (TNFa)
- Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6 [ Time Frame: baseline and week 6 ]Secondary outcomes include changes in steady-state GSH levels in beryllium specific CD4+ T cell in bronchoalveolar lavage fluid (BALF)
- HDAC2 Levels [ Time Frame: baseline and week 6 ]Secondary outcomes include changes in HDAC2 levels
- Glucocorticoid Receptors [ Time Frame: baseline and week 6 ]Secondary outcomes include changes in glucocorticoid receptors modification in PBMCs and BAL cells.
- Lung Function [ Time Frame: baseline and week 6 ]Secondary outcomes include changes in lung function, which will be assessed with Forced expiratory volume in 1 second percent predicted (FEV1), Forced vital capacity percent predicted (FVC) and Diffusing capacity percent predicted (DLCO).

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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);

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088243
United States, Colorado | |
National Jewish Health | |
Denver, Colorado, United States, 80206 |
Principal Investigator: | Lisa A. Maier, M.D., MSPH | National Jewish Health | |
Principal Investigator: | Brian Day, PhD | National Jewish Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lisa Maier, Associate Professor of Medicine, National Jewish Health |
ClinicalTrials.gov Identifier: | NCT01088243 History of Changes |
Other Study ID Numbers: |
HS-2360B |
First Posted: | March 17, 2010 Key Record Dates |
Results First Posted: | December 12, 2017 |
Last Update Posted: | January 10, 2018 |
Last Verified: | December 2017 |
Keywords provided by Lisa Maier, National Jewish Health:
Berylliosis Beryllium Disease |
Additional relevant MeSH terms:
Berylliosis Pneumoconiosis Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Lung Injury Occupational Diseases Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |