NCT01801657

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

February 25, 2013

Last Update Submit

March 11, 2014

Conditions

Bronchiectasis

Keywords

bronchiectasisexacerbationvirus

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 year

Secondary Outcomes (6)

  • The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.

    1 year

  • The effect of respiratory virus on lung function

    1 year

  • The effect of respiratory virus infection on the bacterial load in bronchiectasis.

    1 year

  • Time to recovery of respective symptom

    1 year

  • The effect of respiratory virus on quality of life in patients with bronchiectasis

    1 year

  • +1 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Patient judged to have poor compliance
  • Cystic fibrosis bronchiectasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Gao YH, Guan WJ, Xu G, Lin ZY, Tang Y, Lin ZM, Gao Y, Li HM, Zhong NS, Zhang GJ, Chen RC. The role of viral infection in pulmonary exacerbations of bronchiectasis in adults: a prospective study. Chest. 2015 Jun;147(6):1635-1643. doi: 10.1378/chest.14-1961.

    PMID: 25412225DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

BronchiectasisVirus Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesInfections

Study Officials

  • Rongchang Chen, MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

  • Nanshan Zhong, MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongchang Chen, MD

CONTACT

020-83062718Chenrc@Vip.163.com

Nanshan Zhong, MD

CONTACT

020-83062718nanshan@vip.163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

CN(1)