COPDNCT02866357
Respiratory Pathogens of Patients With Asthma and COPD Exacerbations
An observational study of COPD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute exacerbation of COPD and asthma who required hospitalization. To identify the HRV subtypes that are associated with COPD and asthmaexacerbations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma and COPD patients
Who may be able to join
- For COPD patients, patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study. AECOPD is defined when a patient with background COPD (with lung function parameters of FEV1/FVC ratio <70%)24 presented with at least two of the following major symptoms (increased dyspnoea, increased sputum purulence, increased sputum volume) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.25,26
- Patients who has background COPD as mentioned above fulfilling the exacerbation criteria
- Age ≥40 years
- For asthma patients, patients who are admitted to the Prince of Wales Hospital with asthma exacerbation will be screened for this study. Acute exacerbation of asthma is defined when an asthma patient presents with increasing dyspnea, wheeze or cough.
- Patients who has background asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable)6 with any of the above exacerbation criteria for at least 2 consecutive days.
- Age ≥18 years
- Control asthma and COPD subjects will be recruited from the respiratory clinic of the Prince of Wales Hospital. Subjects will be matched for age, sex and lung function of the COPD and asthma subjects. All recruited COPD subjects should have FEV1/FVC ratio of <70%. For asthma patients, they should have a clinical diagnosis of asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable). These subjects should have no exacerbation of asthma or COPD 6 weeks prior to the assessment.
Who cannot join
- History of lung resection or other significant pulmonary disease like pulmonary fibrosis.
- Active infection like pulmonary tuberculosis
- Unable to complete assessment due to physical and/or cognitive impairment
- Having short life expectancy like subjects with terminal malignancy or intractable heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiplex Molecular Detection of Respiratory Pathogens of Adult Patients Admitted to Hospital for Exacerbation of Asthma and Chronic Obstructive Pulmonary Disease and Their Clinical Outcomes.
To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute exacerbation of COPD and asthma who required hospitalization.
To identify the HRV subtypes that are associated with COPD and asthmaexacerbations.
To assess if the infective aetiologies have associations with the clinical outcome of the patients.
Read the detailed description
Objective: Chronic obstructive pulmonary disease (COPD) and asthma exacerbations both contribute to significant health care burden. Viral infections are important cause of acute exacerbation of COPD and asthma.
Hypothesis to be tested: 1. Assess infective etiologies by Multiplex Molecular Detection of nasopharyngeal aspirate (NPA) of patients with acute exacerbation of COPD and asthma; 2. Identify the human rhinovirus (HRV) (the commonest virus causing exacerbations) subtypes involved; 3.Assess if the infective etiologies have associations with clinical outcome of the patients.
Design and subjects: Prospective observational study. Patients admitted to hospital for acute exacerbation of COPD and asthma. Stable COPD and asthma patients will be recruited as controls.
Study instruments: Multiplex Molecular Detection of respiratory pathogens from NPA. Clinical data of the patient will be collected and spirometry will be performed.
Interventions: NPA collection from subjects. Main outcome measures: Primary aim is assessment of the prevalence of different viruses in relation to acute exacerbation of asthma and COPD. Secondary aim is to assess if a certain pathogen is associated with clinical outcomes including duration of hospitalization and 30 and 60 day readmissions and mortality Data analysis: Data will be analyzed by the Statistical Package of the Social Science Statistical software for Window, Version 22 (IBM SPSS Inc, IL, USA). Statistical methods including chi-square test, student t test and ANOVA will be used as appropriate.
Expected results: Understanding the epidemiology of respiratory viruses in COPD and asthma exacerbations allows further investigations of treatment options and gives information about the prognosis.
- Conditions
- COPD
- Being tested
- No intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Just collection of nasopharyngeal aspirate for assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different types of viruses
Prevalence of different types of viruses
Measured: 1 month
Secondary outcomes (1)
Clincial outcomes
The secondary aim is to assess if a certain pathogen has association with clinical outcomes including duration of hospitalization and 30 and 60 day readmissions and mortality.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018
- Study completionDec 2018
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 COPDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanny W.S. Ko, Chinese University of Hong Kong
- Investigators
- David S Hui, MD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866357
- Sponsor's protocol ID
- COPD-asthma microb_v02
- Status last verified
- Jan 2019
- First submitted
- 10 Aug 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ko FW, Chan PK, Chan RWY, Chan KP, Ip A, Kwok A, Ngai JC, Ng SS, On CT, Hui DS. Molecular detection of respiratory pathogens and typing of human rhinovirus of adults hospitalized for exacerbation of asthma and chronic obstructive pulmonary disease. Respir Res. 2019 Sep 13;20(1):210. doi: 10.1186/s12931-019-1181-0.
PubMed 31519188
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiplex Molecular Detection of Respiratory Pathogens of Adult Patients Admitted to Hospital for Exacerbation of Asthma and Chronic Obstructive Pulmonary Disease and Their Clinical Outcomes.
- ClinicalTrials.gov ID
- NCT02866357
- Acronym / sponsor ID
- COPD-asthma microb_v02
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Aug 2016 (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.
To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute exacerbation of COPD and asthma who required hospitalization.
To identify the HRV subtypes that are associated with COPD and asthmaexacerbations.
To assess if the infective aetiologies have associations with the clinical outcome of the patients.
Detailed description
Objective: Chronic obstructive pulmonary disease (COPD) and asthma exacerbations both contribute to significant health care burden. Viral infections are important cause of acute exacerbation of COPD and asthma.
Hypothesis to be tested: 1. Assess infective etiologies by Multiplex Molecular Detection of nasopharyngeal aspirate (NPA) of patients with acute exacerbation of COPD and asthma; 2. Identify the human rhinovirus (HRV) (the commonest virus causing exacerbations) subtypes involved; 3.Assess if the infective etiologies have associations with clinical outcome of the patients.
Design and subjects: Prospective observational study. Patients admitted to hospital for acute exacerbation of COPD and asthma. Stable COPD and asthma patients will be recruited as controls.
Study instruments: Multiplex Molecular Detection of respiratory pathogens from NPA. Clinical data of the patient will be collected and spirometry will be performed.
Interventions: NPA collection from subjects. Main outcome measures: Primary aim is assessment of the prevalence of different viruses in relation to acute exacerbation of asthma and COPD. Secondary aim is to assess if a certain pathogen is associated with clinical outcomes including duration of hospitalization and 30 and 60 day readmissions and mortality Data analysis: Data will be analyzed by the Statistical Package of the Social Science Statistical software for Window, Version 22 (IBM SPSS Inc, IL, USA). Statistical methods including chi-square test, student t test and ANOVA will be used as appropriate.
Expected results: Understanding the epidemiology of respiratory viruses in COPD and asthma exacerbations allows further investigations of treatment options and gives information about the prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma and COPD patients
Key inclusion criteria (7 listed)
- For COPD patients, patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study. AECOPD is defined when a patient with background COPD (with lung function parameters of FEV1/FVC ratio <70%)24 presented with at least two of the following major symptoms (increased dyspnoea, increased sputum purulence, increased sputum volume) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.25,26
- Patients who has background COPD as mentioned above fulfilling the exacerbation criteria
- Age ≥40 years
- For asthma patients, patients who are admitted to the Prince of Wales Hospital with asthma exacerbation will be screened for this study. Acute exacerbation of asthma is defined when an asthma patient presents with increasing dyspnea, wheeze or cough.
- Patients who has background asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable)6 with any of the above exacerbation criteria for at least 2 consecutive days.
Key exclusion criteria (4 listed)
- History of lung resection or other significant pulmonary disease like pulmonary fibrosis.
- Active infection like pulmonary tuberculosis
- Unable to complete assessment due to physical and/or cognitive impairment
- Having short life expectancy like subjects with terminal malignancy or intractable heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionJust collection of nasopharyngeal aspirate for assessment | Other | – |
Primary outcome
Prevalence of different types of viruses
Time frame: 1 month
Prevalence of different types of viruses
1 secondary outcome
Clincial outcomes
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 31519188Ko FW, Chan PK, Chan RWY, Chan KP, Ip A, Kwok A, Ngai JC, Ng SS, On CT, Hui DS. Molecular detection of respiratory pathogens and typing of human rhinovirus of adults hospitalized for exacerbation of asthma and chronic obstructive pulmonary disease. Respir Res. 2019 Sep 13;20(1):210. doi: 10.1186/s12931-019-1181-0.
- Individual participant dataSharing planned: No
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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.
David S Hui, MD study chair
Chinese University of Hong Kong
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 COPD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 1 Feb 2019. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different types of viruses (time frame: 1 month). 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 NCT02866357, 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 1 Feb 2019.