The Effects of N-Acetylcysteine on Oxidative Stress Markers in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Level of 8 - isoprostane, MDA and DNA damage in sputum
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a condition defined as a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of lungs to noxious particles or gases, primarily caused by cigarette smoking. The accelerated decline in lung function is closely associated with an increased number of neutrophils in the sputum and hence with higher level of airway inflammation. It becomes clear that the inflammatory process potentiates as COPD progresses and exerts damage which is irreversible. Oxidative stress is inextricably linked to the inflammatory response.
There is increasing evidence that an oxidant/antioxidant imbalance, in favor of oxidants, occurs in COPD.
NAC has been reported to reduce the viscosity of sputum in both cystic fibrosis and COPD, facilitating the removal of pulmonary secretions. Moreover, by maintaining the airway clearance, it prevents bacterial stimulation of mucin production and hence mucus hypersecretion.
The superiority of NAC over the other mucolytics may be in its anti-inflammatory and antioxidant properties and its mucolytic actions.
The aim of this study is to evaluate the effects of treatment with NAC long on oxidative stress marker change and also explore the effect of NAC to airway inflammatory, lung function test and CAT scores. Selected oxidative stress marker was defined as 8 - isoprostane, protein carbonyl, DNA damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible stable COPD patients who are currently treated with only short-acting bronchodilator (salbutamol or fenoterol/ipratropium bromide) or long-acting bronchodilator (LABA or LAMA) or inhaled corticosteroids/LABA
- •Pre-bronchodilator FEV1 ≥ 80% and < 80% predicted
- •Current or ex-smokers (≥ 10 pack year)
排除标准
- •Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung and other malignancies
- •Recent acute coronary syndrome (within 12 weeks)
- •Cerebrovascular disease without neurological recovery
- •Cognitive impairment
- •Recent acute exacerbation of COPD (within 4 weeks)
- •Recent respiratory viral infection (within 4 weeks)
- •Could not provide adequate sputum specimens
- •Develop worsening of COPD symptoms during sputum induction
- •Could not provide informed consent
研究组 & 干预措施
N-acetylcysteine treatment
All COPD patients will be treated with N-acetylcysteine at the dose of 1200 mg per day (600 mg three times a day) for 4 weeks in addition to their current COPD medications without other mucolytic agents
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Level of 8 - isoprostane, MDA and DNA damage in sputum
时间窗: 4 weeks
To measure the different level of 8 - isoprostane, MDA and DNA damage in sputum before and after treated with NAC long in patients in this study, Reduce from first measurement. The level of 8 - isoprostane, MDA and DNA damage are reported according to ELISA based on the manufacturer's instructions.
次要结局
- Percentage of Neutrophil in sputum(4 weeks)
- FVC(4 weeks)
- COPD Assessment Test (CAT TM)(4 weeks)
- FEV1(4 weeks)
- FEV1/FVC(4 weeks)
研究者
Kittipong Maneechotesuwan
Professor
Siriraj Hospital