Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.
研究概览
简要总结
The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, the investigators will analyze the effect of long-term treatment with azithromycin (250 mg three times per week during three months) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis.
详细描述
The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, we will analyze the effect of long-term treatment with azithromycin (AZ) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis. Patients will be randomized in an open label model to receive AZ 250 mg three times per week during three months or nothing.Dyspnea (Borg scale), exacerbations (Nº) in the last three months, sputum volume (cc), sputum colour (15-point scale), and health related quality of life (Questionnaire St.George) will be measured in both groups before and after treatment. Lung function, sputum culture, CT scan (Bhalla score) and inflammatory markers in blood (ESR, PCR),exhaled air (Nitric Oxide,) and exhaled condensed air (pH, nitrites, isoprostane) will be assessed before and after treatment. Relationships between clinical and inflammatory markers will be studied
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of bronchiectasis based on lung HRCT and clinical symptoms
- •Clinically stable in previous four weeks without exacerbations
- •Informed consent
排除标准
- •Bronchiectasis secondary to Cystic fibrosis, pulmonary surgical processes, immune deficiency, emphysema, allergic bronchopulmonary aspergillosis or diffuse interstitial pulmonary diseases
- •Intolerance to macrolides or severe liver disease.
研究组 & 干预措施
azithromycin
treatment with azithromycin during three months
干预措施: Azithromycin (Drug)
结局指标
主要结局
Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.
时间窗: Before and after three months of treatment
Oxidative stress and NO metabolism in airway were investigated by measuring pH and the concentration of 8-isoprostane, nitrites (NO2-) and nitrates (NO3-) in EBC. Exhaled NO was also determined in all patients.
次要结局
- colour and volume sputum,(Before and after three months of treatment)
- Impact on functional capacity and health related quality of life(Before and after three months of treatment)
- Number of Exacerbations(Before and after three months of treatment)
- changes in lung function(Before and after three months of treatment)
- Changes in HRCT Lung scores(Before and after three months of treatment)