Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- myeloperoxidase in induced sputum
研究概览
简要总结
COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.
详细描述
Rationale:
COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis.
Objective:
To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients.
Study population:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GOLD II or III COPD (GOLD II: FEV1/FVC < 70%; 50% < FEV1 < 80% predicted, GOLD III: FEV1/FVC < 70%; 30% < FEV1 < 50% predicted ).
- •Stable disease (no exacerbations in the last 3 months).
- •Age > 40 yrs.
- •Written informed consent.
排除标准
- •Infections and/or use of antibiotics in the last month.
- •Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).
- •Allergy for tetracyclines or a history of substantial side-effects.
- •Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
- •Acute exacerbation of COPD as defined by Anthonisen et al. [10].
- •Signs and/or symptoms of a current respiratory or non-respiratory infection.
- •Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.
研究组 & 干预措施
1
Doxycycline 100mg daily
干预措施: Doxycycline (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
myeloperoxidase in induced sputum
时间窗: 3 weeks
次要结局
- MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.(3 weeks)
- Lung function (FEV1)(3 weeks)
- Symptom scores(3 weeks)