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NCT Number: NCT01587001

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetyl-cysteine

Dietary Supplement

900mg three times daily for 8 weeks

Placebo

Drug

Matching placebo three times daily for 8 weeks.

Primary outcomes

  1. Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels

    Time frame: 8 weeks of anti-oxidant therapy

    Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)

Secondary outcomes

  1. Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels

    Time frame: 8 weeks of anti-oxidant therapy

    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.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • American Thoracic Society

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 27, 2012
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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