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

NCT01587001 | Completed Results DMC

• 1 other identifier: 22219201
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Sarcoidosis

Keywords

Sarcoidosis; oxidative stress; anti-oxidant

Outcome Measures

Primary Outcomes (1)

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

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

  8 weeks of anti-oxidant therapy

Secondary Outcomes (1)

• Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels

  8 weeks of anti-oxidant therapy

Study Arms (2)

Oral N-acetyl-cysteine

ACTIVE COMPARATOR

oral NAC 900mg three times daily for 8 weeks

Dietary Supplement: N-acetyl-cysteine

Matching Placebo

PLACEBO COMPARATOR

oral placebo three times daily for 8 weeks

Drug: Placebo

Interventions

N-acetyl-cysteine DIETARY_SUPPLEMENT

900mg three times daily for 8 weeks

Oral N-acetyl-cysteine

Placebo DRUG

Matching placebo three times daily for 8 weeks.

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Jewish Health: lead
• American Thoracic Society: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Sarcoidosis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Nabeel Hamzeh
• Organization: National Jewish Health

hamzehn@njhealth.org

303-270-2613

Study Officials

• Nabeel Hamzeh, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: April 27, 2012
• Study Start: November 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 4, 2020
• Results First Posted: July 26, 2016

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)