Trial · NCT01088243
Targeting Oxidative Stress in Chronic Beryllium Disease
NCT01088243, Phase 1, Phase 2, Completed, National Jewish Health; results first posted 2017-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeting Oxidative Stress in Chronic Beryllium Disease. Trials, record NCT01088243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01088243
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeting Oxidative Stress in Chronic Beryllium Disease
- NCT number
- NCT01088243
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Jewish Health
- Conditions
- Chronic Beryllium Disease
- Interventions
- Mesalamine, Placebo
- First posted
- 2010-03-17
- Last updated
- 2018-10-12
- Results first posted
- 2017-12-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 | 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. |
| Secondary | Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa) | baseline and week 6 | Secondary outcomes include changes in bronchoalveolar lavage (BAL) tumor necrosis factor alpha (TNFa) |
| Secondary | Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6 | baseline and week 6 | Secondary outcomes include changes in steady-state GSH levels in beryllium specific CD4+ T cell in bronchoalveolar lavage fluid (BALF) |
| Secondary | HDAC2 Levels | baseline and week 6 | Secondary outcomes include changes in HDAC2 levels |
| Secondary | Glucocorticoid Receptors | baseline and week 6 | Secondary outcomes include changes in glucocorticoid receptors modification in PBMCs and BAL cells. |
| Secondary | Lung Function | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 | baseline and week 6 | Because bronchoscopy was not required for participation, only three placebo and six 5-ASA-treated subjects underwent bronchoscopy and is reported under BAL. | Stimulation index | MEAN |
| SECONDARY | Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa) | baseline and week 6 | We did not have sufficient cells to run experiments on all participants. However, below is a summary of what data was received. | pg/ml | MEAN |
| SECONDARY | Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6 | baseline and week 6 | We did not receive enough cells from participants to be able to run experiments on all. However, below is a summary of what data was received. | mmol/mg | MEAN |
| SECONDARY | HDAC2 Levels | baseline and week 6 | We were not able to perform due to insufficient samples and data collected from each participant to summarize changes in HDAC2 levels. | ||
| SECONDARY | Glucocorticoid Receptors | baseline and week 6 | We were not able to perform due to insufficient samples and data collected from each participant to summarize changes. | ||
| SECONDARY | Lung Function | baseline and week 6 | One participant did not complete follow up in Mesalamine group. However, below is a summary of what data was received. | percentage of predicted value | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 | Mesalamine | BAL | 48.61 | Standard Deviation 57.18 | Stimulation index |
| Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 | Placebo | BAL | 9.33 | Standard Deviation 14.08 | Stimulation index |
| Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 | Mesalamine | PBMC | 22.07 | Standard Deviation 20.30 | Stimulation index |
| Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6 | Placebo | PBMC | 3.8 | Standard Deviation 6.09 | Stimulation index |
| Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa) | Mesalamine | 62 | Standard Deviation 35.76 | pg/ml | |
| Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa) | Placebo | -1750 | Standard Deviation 2734 | pg/ml | |
| Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6 | Mesalamine | 4.93 | Standard Deviation 20.08 | mmol/mg | |
| Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6 | Placebo | 10.38 | Standard Deviation 16.5 | mmol/mg | |
| Lung Function | Mesalamine | FEV1 % pred | 2.2 | Standard Deviation 4.49 | percentage of predicted value |
| Lung Function | Placebo | FEV1 % pred | -0.91 | Standard Deviation 4.73 | percentage of predicted value |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mesalamine | 13 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Mesalamine | 12 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Mesalamine | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mobitz Type II heart block | Cardiac disorders | Mesalamine | 0 | 13 | 0 |
| other | Mobitz Type II heart block | Cardiac disorders | Placebo | 1 | 5 | 1 |
| other | Swelling | Skin and subcutaneous tissue disorders | Mesalamine | 0 | 13 | 0 |
| other | Swelling | Skin and subcutaneous tissue disorders | Placebo | 1 | 5 | 1 |
| other | One 5-ASA-treated subject developed dizziness, constipation, stomach pain and chest pain two weeks | General disorders | Mesalamine | 1 | 13 | 1 |
| other | One 5-ASA-treated subject developed dizziness, constipation, stomach pain and chest pain two weeks | General disorders | Placebo | 0 | 5 | 0 |
| other | One 5-ASA-treated subject experienced coughing and low energy after the follow-up bronchoscopy | General disorders | Mesalamine | 1 | 13 | 1 |
| other | One 5-ASA-treated subject experienced coughing and low energy after the follow-up bronchoscopy | General disorders | Placebo | 0 | 5 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mesalamine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mesalamine | 2 | 13 |
| Total, other adverse events | Placebo | 2 | 5 |
| Total, serious adverse events | Mesalamine | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mesalamine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01088243
GET https://conductscience.org/api/trials/v1/NCT01088243/registered