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| Name | Class |
|---|---|
| American Thoracic Society | OTHER |
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This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis.
Sarcoidosis is a granulomatous lung disease predominantly affecting the lungs. Reactive oxidative species are produced secondary to oxidative stress and inflammation and can affect key cellular processes. The investigators have shown a role for oxidative stress in chronic beryllium disease (CBD), a granulomatous disease that resembles sarcoidosis, and have also shown that antioxidant therapy reduces inflammation in CBD. Oxidative stress also plays a role in sarcoidosis but the exact mechanism and potential effect of antioxidant therapy on sarcoidosis is unknown. The investigators propose conducting a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis. The investigators will measure and compare markers of inflammation and oxidative stress in the lungs of sarcoidosis patients before and after treatment with NAC. The results of this study will prepare the investigators for a larger study investigating the role of NAC as a therapy for sarcoidosis with changes in lung function and x-ray as our primary outcome. This will provide the investigators with a new non-toxic therapy for sarcoidosis that can be used on its own or to supplement other therapies minimizing their toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral N-acetyl-cysteine | Active Comparator | oral NAC 900mg three times daily for 8 weeks |
|
| Matching Placebo | Placebo Comparator | oral placebo three times daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl-cysteine | Dietary Supplement | 900mg three times daily for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels | Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml) | 8 weeks of anti-oxidant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels | We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo. | 8 weeks of anti-oxidant therapy |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabeel Hamzeh, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral N-acetyl-cysteine | N-acetyl-cysteine: 900mg three times daily for 8 weeks |
| FG001 | Matching Placebo | Placebo: Matching placebo three times daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral N-acetyl-cysteine | oral NAC 900mg three times daily for 8 weeks N-acetyl-cysteine: 900mg three times daily for 8 weeks |
| BG001 | Matching Placebo | Placebo: Matching placebo three times daily for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels | Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml) | Posted | Mean | Standard Deviation | pg/ml | 8 weeks of anti-oxidant therapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral N-acetyl-cysteine | N-acetyl-cysteine: 900mg three times daily for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nabeel Hamzeh | National Jewish Health | 303-270-2613 | hamzehn@njhealth.org |
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| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Matching placebo three times daily for 8 weeks. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels | We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo. | Posted | Mean | Standard Deviation | nmol/mg protein | 8 weeks of anti-oxidant therapy |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Matching Placebo | Placebo: Matching placebo three times daily for 8 weeks. | 0 | 3 | 0 | 3 |
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| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |