The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/5/2014 |
| Start Date: | November 2011 |
| End Date: | October 2014 |
| Contact: | Nabeel Y Hamzeh, MD |
| Email: | hamzehn@njhealth.org |
| Phone: | 303-270-2613 |
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.
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.
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.
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