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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
yonghua gao, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01801657
First received: February 25, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition
Bronchiectasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults

Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The effect of respiratory virus infection on systemic and pulmonary inflammatory markers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bronchiectasis,stable
A patient was defined as stable if there was no exacerbation for the previous 4 wk
Bronchiectasis,exacerbations
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with non-CF bronchiectasis diagnosed by High Resolution CT(HRCT) attending the out-patient clinics of First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,China

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient judged to have poor compliance
  • Cystic fibrosis bronchiectasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801657

Contacts
Contact: Rongchang Chen, MD 020-83062718 Chenrc@Vip.163.com
Contact: Nanshan Zhong, MD 020-83062718 nanshan@vip.163.com

Locations
China, Guangdong
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    nanshan@vip.163.com   
Sub-Investigator: Yonghua Gao, PHD         
Sub-Investigator: Gang Xu, PHD         
Sub-Investigator: Weijie Guan, PHD         
Sub-Investigator: Zhiya Lin, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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
  More Information

No publications provided

Responsible Party: yonghua gao, PHD, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01801657     History of Changes
Other Study ID Numbers: 2009CB522109
Study First Received: February 25, 2013
Last Updated: March 11, 2014
Health Authority: China: Ethics Committee

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
bronchiectasis
exacerbation
virus

Additional relevant MeSH terms:
Bronchiectasis
Virus Diseases
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014