The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis

Pulmonary Sarcoidosis Clinical Trial

Official title:

The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587001
• Other study ID #: 22219201
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Dietary Supplement:
• N-acetyl-cysteine
900mg three times daily for 8 weeks

Drug:
• Placebo
Matching placebo three times daily for 8 weeks.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	American Thoracic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-a Levels	Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-a levels (pg/ml)	8 weeks of anti-oxidant therapy
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.	8 weeks of anti-oxidant therapy