Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
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.
研究概览
详细说明
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:
Thirty patients with stable GOLD II COPD.
Intervention:
Placebo versus doxycycline in randomised design.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Noord-Holland
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Alkmaar、Noord-Holland、荷兰、1815JD
- Medical Center Alkmaar
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：2个
安慰剂
|
Placebo tablets 100mg
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实验性的：1
Doxycycline 100mg daily
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Doxycycline tablets, 100mg daily
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
myeloperoxidase in induced sputum
大体时间：3 weeks
|
3 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.
大体时间：3 weeks
|
3 weeks
|
|
Lung function (FEV1)
大体时间：3 weeks
|
3 weeks
|
|
Symptom scores
大体时间：3 weeks
|
3 weeks
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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