跳至主要内容
临床试验/NCT01587001
NCT01587001已完成不适用

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

National Jewish Health1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Oral N-acetyl-cysteine

Active Comparator

oral NAC 900mg three times daily for 8 weeks

干预措施: N-acetyl-cysteine (Dietary Supplement)

Matching Placebo

Placebo Comparator

oral placebo three times daily for 8 weeks

干预措施: Placebo (Drug)

结局指标

主要结局

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

时间窗: 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)

次要结局

  • Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels(8 weeks of anti-oxidant therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验