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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Thoracic Society
Information provided by (Responsible Party):
Nabeel Hamzeh, National Jewish Health
ClinicalTrials.gov Identifier:
NCT01587001
First received: January 10, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pulmonary Sarcoidosis
Dietary Supplement: N-acetyl-cysteine
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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 Drug: Placebo
Matching placebo three times daily for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nabeel Hamzeh, Principal Investigator, National Jewish Health
ClinicalTrials.gov Identifier: NCT01587001     History of Changes
Other Study ID Numbers: 22219201
Study First Received: January 10, 2012
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Antioxidants
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on July 23, 2014