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临床试验/NCT01801657
NCT01801657Unknown不适用

The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults

The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable.

研究概览

简要总结

Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway flow limitation, which may be accompanied by recurrent exacerbations.It has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. However,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.This study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis.

详细描述

Bronchiectasis is a chronic airway disease characterised by a vicious cycle of persistent bacterial colonization,inflammation and progressive tissue destruction.Patients with bronchiectasis frequently developed acute exacerbations characterised by acute worsening requiring changes in concomitant use of medication,with attendant adverse effects on their morbidity and health-related quality of life. The detailed pathogenesis of exacerbations of bronchiectasis, however, remains poorly understood.

Recent data suggested that airway infection and inflammation are important drivers of exacerbations,therefore the imbalance between chronic bacterial infection and host immune response may result in bronchiectasis exacerbations. Viral infection may be an important factor that leads to this events.It has been established that respiratory viruses are mainly responsible for the exacerbations of other chronic respiratory diseases, i.e. asthma, COPD and cystic fibosis. However, the data regarding prospective studies that sought to investigate the roles of viruses in acute exacerbation of bronchiectasis are lacking. Furthermore,the associations between viruses and bacteria during exacerbation need to be assessed. This study targets at indentifying the frenquency of common viral infections in adults with non-cystic fibrosis bronchiectasis and may shed light on the effects they have on clinical parameters,i.e. the length of exacerbated symptom to recovery,lung function, pulmonary inflammation, bacterial load and quality of life.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • HRCT-diagnosed Bronchiectasis
  • Capable of providing written informed consent

排除标准

  • Patient judged to have poor compliance
  • Cystic fibrosis bronchiectasis

结局指标

主要结局

The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable.

时间窗: 1 year

Respiratory viruses in the nasal swab and sputum will be identified using the polymerase chain reaction(PCR)technique when clinically stable and during exacerbation.The following viruses will be tested for:influenza A,B(including influenza A H1N1),respiratory syncytial virus(RSV),Enterovirus,Parainfluenza 1-4,Rhinovirus,human Coronaviruses(subtypes OC43、229E、HKU1),human metapneumovirus,adenovirus, human bocavirus,chlamydia,mycoplasma.

次要结局

  • The effect of respiratory virus infection on the bacterial load in bronchiectasis.(1 year)
  • The effect of respiratory virus on quality of life in patients with bronchiectasis(1 year)
  • To investigate if upper respiratory tract symptoms are associated with viral infections.(1 year)
  • The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.(1 year)
  • Time to recovery of respective symptom(1 year)
  • The effect of respiratory virus on lung function(1 year)

研究者

发起方
The First Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

yonghua gao

PHD

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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