The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pulmonary Sarcoidosis |
Dietary Supplement: N-acetyl-cysteine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis |
- Effect of an oral anti-oxidant on lung inflammation [ Time Frame: change in lung inflammation after 8 weeks of anti-oxidant therapy ] [ Designated as safety issue: No ]Association of oxidative stress with inflammatory markers in the lungs of sarcoidosis patients and the effect of an 8 week course of an oral anti-oxidant on the levels of oxidative stress and inflammation.
- Effect of an oral anti-oxidant on lung oxidative stress [ Time Frame: change in lung oxidative stress after 8 weeks of anti-oxidant therapy ] [ Designated as safety issue: No ]Association of oxidative stress with inflammatory markers in the lungs of sarcoidosis patients and the effect of an 8 week course of an oral anti-oxidant on the levels of oxidative stress and inflammation.
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oral N-acetyl-cysteine
oral NAC 900mg twice daily for 8 weeks
|
Dietary Supplement: N-acetyl-cysteine
900mg twice daily for 8 weeks
|
| Placebo Comparator: Matching Placebo |
Drug: Placebo
Matching placebo twice daily for 8 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Biopsy proven sarcoidosis.
- Pulmonary parenchymal involvement with a Scadding chest x-ray stage II, III or IV.
- Abnormal spirometry and/or DLCO (< 80% of predicted).
- Consenting adults : Age 18 years and above
Exclusion Criteria:
- Positive lung washing or biopsy cultures for fungi or mycobacterial disease;
- Presence of other co-morbid conditions that may affect the patient's outcome.
- Patient inability to undergo venipuncture and BAL procedures.
- Current use of tobacco (smoking or otherwise) in the past 6 months
- Treatment with immunosuppressive therapy within the past 6 months.
- On oral anti-oxidant supplements.
- Active peptic ulcer disease.
Contacts and Locations| Contact: Nabeel Y Hamzeh, MD | 303-270-2613 | hamzehn@njhealth.org |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Principal Investigator: Nabeel Hamzeh, MD | |
| Principal Investigator: | Nabeel Hamzeh, MD | National Jewish Health |
More Information
No publications provided
| Responsible Party: | Nabeel Hamzeh, Principal Investigator, National Jewish Health |
| ClinicalTrials.gov Identifier: | NCT01587001 History of Changes |
| Other Study ID Numbers: | 22219201 |
| Study First Received: | January 10, 2012 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Jewish Health:
|
Sarcoidosis oxidative stress anti-oxidant |
Additional relevant MeSH terms:
|
Sarcoidosis Sarcoidosis, Pulmonary Lymphoproliferative Disorders Lymphatic Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Acetylcysteine N-monoacetylcystine Antioxidants Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on October 17, 2012
