The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults
|ClinicalTrials.gov Identifier: NCT01801657|
Recruitment Status : Unknown
Verified March 2014 by yonghua gao, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was: Recruiting
First Posted : March 1, 2013
Last Update Posted : March 12, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||April 2014|
A patient was defined as stable if there was no exacerbation for the previous 4 wk
Bronchiectasis exacerbations were defined by subjective and persistent(>24 h) deterioration in at least three respiratory symptoms, including cough, dyspnea, hemoptysis, increased sputum purulence or volume, chest pain (with or without fever), radiographic deterioration, systemic disturbances, or changes in chest auscultation
- The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable. [ Time Frame: 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.
- The effect of respiratory virus infection on systemic and pulmonary inflammatory markers. [ Time Frame: 1 year ]Systemic and airway inflammatory cytokines including IL-1β、IL-6、IL-8、TNF-a were measured using a commercial multiplex bead-based assay.
- The effect of respiratory virus on lung function [ Time Frame: 1 year ]Spirometric indices in the present study is referred to as forced expiratory vilume in 1s(FEV1),forced vital capacity(FVC).Spirometry tests are carried out using a spirometer (COSMED, QUARK PFT, Italy). All operation procedures meet the joint recommendation by ATS and ERS. A total of at least 3 (not more than 8) spirometric maneuvers are performed, with the variation between the best two maneuvers of <5% or 200ml in FVC and FEV1. The maximal values of FVC and FEV1 are reported.
- The effect of respiratory virus infection on the bacterial load in bronchiectasis. [ Time Frame: 1 year ]Type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter
- Time to recovery of respective symptom [ Time Frame: 1 year ]The time from exacerbation onset by which a 3-d moving average was equal to or exceeded the baseline value
- The effect of respiratory virus on quality of life in patients with bronchiectasis [ Time Frame: 1 year ]Quality of life in patients with bronchiectasis were measured by St.George Respiratory Questionnaire、Leicester Cough Questionnaire and COPD assessment test during exacerbations,and then compared between virus-postive and virus-negative patients
- To investigate if upper respiratory tract symptoms are associated with viral infections. [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801657
|Contact: Rongchang Chen, MD||020-83062718||Chenrc@Vip.163.com|
|Contact: Nanshan Zhong, MDfirstname.lastname@example.org|
|The First Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Rongchang Chen, MD 020-83062718 Chenrc@vip.163.com|
|Contact: Nanshan Zhong, MD 020-83062718 email@example.com|
|Sub-Investigator: Yonghua Gao, PHD|
|Sub-Investigator: Gang Xu, PHD|
|Sub-Investigator: Weijie Guan, PHD|
|Sub-Investigator: Zhiya Lin, PHD|
|Principal Investigator:||Rongchang Chen, MD||The First Affiliated Hospital of Guangzhou Medical University|
|Principal Investigator:||Nanshan Zhong, MD||The First Affiliated Hospital of Guangzhou Medical University|