The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary 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.
|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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Oral N-acetyl-cysteine
oral NAC 900mg three times daily for 8 weeks
Dietary Supplement: N-acetyl-cysteine
900mg three times daily for 8 weeks
|Placebo Comparator: Matching Placebo||
Matching placebo three times daily for 8 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587001
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||Nabeel Hamzeh, MD||National Jewish Health|