BronchiectasisNCT01801657
The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults
An observational study of Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age ≥ 18 years
- HRCT-diagnosed Bronchiectasis
- Capable of providing written informed consent
Who cannot join
- Patient judged to have poor compliance
- Cystic fibrosis bronchiectasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Rongchang Chen, MD, 020-83062718, Chenrc@vip.163.com
Nanshan Zhong, MD, 020-83062718, nanshan@vip.163.com
About this study
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.
Read the 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.
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, exacerbation, virus
- Medical subject headings
- Bronchiectasis, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.
Systemic and airway inflammatory cytokines including IL-1β、IL-6、IL-8、TNF-a were measured using a commercial multiplex bead-based assay.
Measured: 1 year
The effect of respiratory virus on lung function
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.
Measured: 1 year
The effect of respiratory virus infection on the bacterial load in bronchiectasis.
Type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter
Measured: 1 year
Time to recovery of respective symptom
The time from exacerbation onset by which a 3-d moving average was equal to or exceeded the baseline value
Measured: 1 year
The effect of respiratory virus on quality of life in patients with bronchiectasis
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
Measured: 1 year
To investigate if upper respiratory tract symptoms are associated with viral infections.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yonghua gao, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical UniversityNanshan Zhong, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801657
- Sponsor's protocol ID
- 2009CB522109
- Status last verified
- Mar 2014
- First submitted
- 25 Feb 2013
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25412225
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults
- ClinicalTrials.gov ID
- NCT01801657
- Acronym / sponsor ID
- 2009CB522109
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, exacerbation, virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- HRCT-diagnosed Bronchiectasis
- Capable of providing written informed consent
Key exclusion criteria (2 listed)
- Patient judged to have poor compliance
- Cystic fibrosis bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.
Time frame: 1 year
The effect of respiratory virus on lung function
Time frame: 1 year
The effect of respiratory virus infection on the bacterial load in bronchiectasis.
Time frame: 1 year
Time to recovery of respective symptom
Time frame: 1 year
The effect of respiratory virus on quality of life in patients with bronchiectasis
Time frame: 1 year
To investigate if upper respiratory tract symptoms are associated with viral infections.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Derived from this study: PubMed 25412225Gao 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.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongchang Chen, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Nanshan Zhong, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongchang Chen, MD (020-83062718, Chenrc@Vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01801657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.