Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- the expression of CXCR3 in blood by flow cytometry and the chemokine IL-4,IFN-γ,CXCL9,CXCL10,CXCL11 and CCL17 in sputum and blood
研究概览
简要总结
This study is to evaluate the expression of biological markers in induced sputum and peripheral blood T lymphocytes of patients with combined pulmonary fibrosis and emphysema (CPFE). The features of CPFE would be observed, including pulmonary function tests and fractional exhaled nitric oxide （FENO）.
详细描述
A new disease including concomitant upper-lobe emphysema and lower-lobe fibrosis in radiology has been defined as (combined pulmonary fibrosis and emphysema, CPFE). CPFE has distinct clinical characteristics with the emphysema and the pulmonary fibrosis, including gender, age, clinical manifestation, pulmonary function tests and prognosis.
Normally Th1/Th2 is balanced. However, patients with emphysema had a significantly higher expression of Th1. On the other hand, higher expression of Th2 is involved in the development of pulmonary fibrosis. The expressions of Th1 and Th2 were proved to play a central role in pathogenesis of emphysema and pulmonary fibrosis, while are still unknown in patients of combined pulmonary fibrosis and emphysema. The study would observe the Th1/Th2 expression, pulmonary function tests , fractional exhaled nitric oxide （FENO）and other features in CPFE patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IPF-alone group: 10 patients meeting the IPF diagnosis criteria without emphysema.
- •CPFE group: 15 patients with CT presentation of concomitant upper-lobe emphysema and lower-lobe fibrosis.
- •Emphysema-alone group: 15 patients with their CT diagnosis of emphysema without fibrosis.
- •Control: 20 healthy sex- and age-matched volunteers including nonsmokers and smokers. None of the healthy volunteers with a history of respiratory diseases.
排除标准
- •Age > 90 or < 50
- •Treated with corticosteroids or other immunomodulatory drugs
- •Some known causes of interstitial lung disease such as collagen vascular disease, drug-induced lung disease, occupational disease.
- •An exacerbation in 4 weeks
- •Subjects had a history of allergic diseases.
结局指标
主要结局
the expression of CXCR3 in blood by flow cytometry and the chemokine IL-4,IFN-γ,CXCL9,CXCL10,CXCL11 and CCL17 in sputum and blood
时间窗: six months
次要结局
- fractional exhaled nitric oxide （FENO）(six months)
- pulmonary function tests(six months)