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临床试验/NCT02826954
NCT02826954已完成不适用

The Nasal Airway in Chronic Obstructive Pulmonary Disease

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
pathological changes in the nose assessed with nasal endoscopy

研究概览

简要总结

The study is based on the theory of a "unified airway" that considers the nose and paranasal sinuses together with lower airways as one integrated unit. The upper and lower respiratory tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes in one portion of the airway, can provoke similar changes throughout the airway. This is well documented in asthmatic patients but documented poorly in patients suffering from chronic obstructive lung disease (COPD).

COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal involvement has been found to directly affect the lower airway, sinonasal disease is under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger project where the goal is to gain knowledge supporting the theory of a "unified airway" in patients with COPD.

Here sinonasal, pulmonary and generic health related quality of life will be studied in a group of patients with COPD versus a control group. The severity of nasal airway obstruction will be linked to the the severity of pulmonary airway obstruction. Assessment of pathological changes in the nose with nasal endoscopy, as well as performing a nasal cytological brushing for the identification of nasal inflammatory responses in the nose, will be conducted in both the control and study group.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of COPD: all stages
  • Healthy individuals for the control group
  • Exclusion Criteria both groups:
  • systemic disease such as Cystic Fibrosis, Kartagener syndrome, sarcoidosis
  • upper airway infection during the last 2 weeks
  • COPD exacerbation during the last 6 weeks
  • previous surgery in the nose and paranasal sinuses
  • ongoing treatment for malignant disease
  • severe depression, Alzheimers disease and Parkinson's disease
  • pregnancy or nursing

排除标准

  • 未提供

结局指标

主要结局

pathological changes in the nose assessed with nasal endoscopy

时间窗: 4 hours

inflammatory responses in the nose identified by nasal cytological brushing

时间窗: 4 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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