NCT02547532已完成不适用
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- composition of microbioma in sputa
研究概览
简要总结
In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment.
- •For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes.
排除标准
- •The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.
结局指标
主要结局
composition of microbioma in sputa
时间窗: 2 years
次要结局
- correlation with clinical and physiological parameters(2 years)
研究者
Bruno Balbi
Head, Pulmonary Rehabilitation Department
Fondazione Salvatore Maugeri
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