Clinical trial NCT01587001: The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
Official title: The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Sarcoidosis
Keywords: Sarcoidosis
oxidative stress
anti-oxidant
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: American Thoracic Society
First posted: 2012-04-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels
timeFrame: 8 weeks of anti-oxidant therapy
Secondary outcomes:
measure: Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels
timeFrame: 8 weeks of anti-oxidant therapy
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Nabeel Hamzeh, MD
role: PRINCIPAL_INVESTIGATOR
References: