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

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ClinicalTrials.gov Identifier: NCT01587001
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : July 26, 2016
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Pulmonary Sarcoidosis Dietary Supplement: N-acetyl-cysteine Drug: Placebo

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
oral placebo three times daily for 8 weeks
Drug: Placebo
Matching placebo three times daily for 8 weeks.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587001


Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
American Thoracic Society
Investigators
Principal Investigator: Nabeel Hamzeh, MD National Jewish Health
More Information

Responsible Party: Jennifer Brandorff, Manager, Clinical Research Services, Regulatory, National Jewish Health
ClinicalTrials.gov Identifier: NCT01587001     History of Changes
Other Study ID Numbers: 22219201
First Posted: April 27, 2012    Key Record Dates
Results First Posted: July 26, 2016
Last Update Posted: April 26, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jennifer Brandorff, 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
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes