Clinical trial NCT01801657: The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults
Official title: The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: bronchiectasis
exacerbation
virus
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable.
timeFrame: 1 year
Secondary outcomes:
measure: The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.
timeFrame: 1 year
measure: The effect of respiratory virus on lung function
timeFrame: 1 year
measure: The effect of respiratory virus infection on the bacterial load in bronchiectasis.
timeFrame: 1 year
measure: Time to recovery of respective symptom
timeFrame: 1 year
measure: The effect of respiratory virus on quality of life in patients with bronchiectasis
timeFrame: 1 year
measure: To investigate if upper respiratory tract symptoms are associated with viral infections.
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Rongchang Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.