Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Inflammatory markers
研究概览
简要总结
Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in the United States. It is projected to be the leading cause of death by 2020. As many as 24 million Americans are estimated to suffer from impaired lung function. Of those more than 12 million were actually diagnosed with COPD, and over 118,000 deaths were attributed to COPD in 2004.
COPD has been linked with an increased risk for lung cancer. Both airway obstruction, defined by abnormal pulmonary function tests (PFTs), and CT scan diagnosed emphysema were shown to be independent risk factors for lung cancer.
Treatment for COPD includes cessation of environmental exposures (i.e. smoking), dampening the inflammatory response, symptoms control and, for a small subgroup, surgical approaches and lung transplant. Nevertheless, the effectiveness of these treatment options to change the natural history of this disease is very limited. Recent evidence suggests a new role for macrolides as immune-modulators in patients with COPD, although the mechanisms are not clearly determined.
The investigators hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •List primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria).
- •Patient must be 50 years old or older.
- •Patient must have a smoking history of at least 20 pack-years
- •Patient must have stable COPD, GOLD 0, I and/or IIA.
- •CT of chest with evidence of emphysema
排除标准
- •List primary criteria for study exclusion (i.e. do not need to enter entire list of inclusion criteria).
- •FEV1 < 70%.
- •Exacerbations (defined as use of oral steroids or antibiotics) in the previous month.
- •Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
- •Diabetes mellitus
- •Renal disease
- •Liver disease
- •Lung cancer
- •ETOH use of more than >6 beers >4 mixed drinks daily
研究组 & 干预措施
Azithromycin
Azithromycin 250mg daily, single daily use for 8 weeks
干预措施: Azithromycin (Drug)
Placebo
Placebo daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Inflammatory markers
时间窗: outcome will be assessed up to two months post initial bronchoscopy
Cytokines in BAL in pg/mL
次要结局
- transcription factor changes(outcome will be assessed up to two months post initial bronchoscopy)
- Lung function changes(outcome will be assessed up to two months post initial bronchoscopy)