Respiratory DisordersNCT03151395
Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific
A study testing Sputum and blood sampling in people with Respiratory Disorders, run by GlaxoSmithKline at 19 sites in 4 countries.
Trial summary
Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Respiratory Disorders
- What is being tested?
- Sputum and blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 25 Aug 2017to 6 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic Diary Card, sputum sampling, pre- and post-bronchodilator spirometry, return for follow-up visits).
- Written informed consent obtained from the subject.
- Male or female aged 40 years or older at the time of enrolment.
- Confirmed diagnosis of moderate to very severe COPD based on post-bronchodilator spirometry (i.e. forced expiratory volume in 1 second [FEV1] over forced vital capacity [FVC] ratio [FEV1/ FVC] < 0.7 and FEV1 < 80% predicted [GOLD grades 2, 3 and 4].
- Stable COPD patient* with documented history** (e.g. medical record verification) of at least 1 moderate or severe AECOPD within the 12 months before study entry.
- Patient for whom the last episode of AECOPD is resolved for at least 30 days at the time of study entry.
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- Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.
- Current or former tobacco smoker (cigarette) with a smoking history of ≥ 10 pack-years OR a subject exposed to biomass smoke for ≥ 20 years.
- Able to provide a sputum sample at Screening Visit.
Who cannot join
- Diagnosed with a respiratory disorder other than COPD (such as sarcoidosis, active tuberculosis or receiving tuberculosis treatment, clinically significant bronchiectasis, lung fibrosis, pulmonary embolism, pneumothorax, lung cancer diagnosed within the previous 5 years, current primary diagnosis of asthma in the opinion of the investigator), or chest X-ray revealing evidence of clinically significant abnormalities not believed to be due to the presence of COPD*. Subjects with allergic rhinitis do not need to be excluded and may be enrolled at the discretion of the investigator.
- A chest X-ray must be taken at Screening Visit, if no chest X-ray taken within the previous 3 months is available.
- Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.
- Undergone or has had lung surgery 12 months before, or plans to have lung surgery 12 months after, study entry.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Received chemotherapy within the 12 months before study entry.
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- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/ product (pharmaceutical product or device).
- Administration of antibiotics within 1 month of study entry OR continuous administration of antibiotics (defined as more than 30 days in total) within 90 days before study entry.
- Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent.
- Contraindication for spirometry testing (such as recent eye surgery, recent thoracic or abdominal surgery procedures, unstable cardiovascular status, recent myocardial infarction or pulmonary embolism).
- Psychiatric illness or any other condition that interferes with the ability to understand the study procedures.
- Pregnant female.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Taiwan6 sites
GSK Investigational Site
Changhua, 500
GSK Investigational Site
Keelung, 20401
GSK Investigational Site
Taichung, 40201
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taichung, 40705
GSK Investigational Site
Taipei, 100
Philippines5 sites
GSK Investigational Site
Iloilo City, 5000
GSK Investigational Site
Jaro, Iloilo City, 5000
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Manila, 1014
GSK Investigational Site
Marilao, Bulacan, 3019
South Korea5 sites
GSK Investigational Site
Bucheon-si, 420-717
GSK Investigational Site
Gangwon-do, 26426
GSK Investigational Site
Incheon, 403-720
GSK Investigational Site
Seoul, 03312
GSK Investigational Site
Seoul, 156-755
Hong Kong3 sites
GSK Investigational Site
Kowloon
GSK Investigational Site
Lai Chi Kok
GSK Investigational Site
Shatin
About this study
Official title: Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific
Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.
Read the detailed description
The protocol has been amended to implement the following changes:
- Alignment of the protocol to the updated GOLD consensus report of 2017 and the COPD fact sheet.
- Alignment of the study endpoints to the study objectives.
- Conditions
- Respiratory Disorders
- Being tested
- Sputum and blood sampling
- Keywords
- COPD, AECOPD, GOLD (Global Initiative for Chronic Obstructive Lung Disease), Asia Pacific
- Medical subject headings
- Respiration Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum and blood samplingOther
Evaluation of the occurrence of potential bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD.
| Study group | Role | What they receive |
|---|---|---|
| Total Group | Other | Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits Receives: Other: Sputum and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDs
The proportion of sputum samples obtained at each visit (confirmed stable or AECOPD visits) and positive for specific bacterial pathogens by bacteriological methods (overall and by bacterial species). Numerator is the number of sputum samples positive for a given pathogen and denominator is the number of visits with a sputum sample tested for a given pathogen. Proportion is computed with 95% confidence intervals. A confirmed stable visit is defined as a scheduled study visit for which the investigator confirms that the subject is stable/ has recovered from a previous exacerbation. Bacterial pathogens include Haemophilus influenzae (Hi), Non-typeable Haemophilus influenzae (NTHi), non-Haemophilus influenzae (Non-Hi), Moraxella catarrhalis (M. catarrhalis), Streptococcus pneumoniae (S. pneumoniae), Staphylococcus aureus (S. aureus), Pseudomonas aeruginosa (P. aeruginosa), Klebsiella pneumoniae (K. pseumoniae), Acinetobacter baumannii (A. baumannii).
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Percentage of Sputum Samples Positive for Viral Pathogens as Identified by Polymerase Chain Reaction (PCR) in Stable COPD Patients and During AECOPDs
The proportion of sputum samples obtained at each visit (confirmed stable visits and AECOPD visits) and positive for specific viral pathogens by PCR (overall and by viral species). The numerator is the number of sputum samples positive for a given pathogen and the denominator is the number of visits with a sputum sample tested for a given pathogen. The proportion is calculated with 95% confidence intervals. Viral pathogens, as identified by PCR, include respiratory syncytial virus (RSV), parainfluenza virus, enterovirus, human rhinovirus (HRV), metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Secondary outcomes (18)
Percentage of Sputum Samples Positive for Bacterial Pathogens in Stable COPD Patients and During AECOPDs, as Identified by PCR
The proportion of sputum samples obtained at each confirmed stable/AECOPD visit and positive for specific bacterial pathogens as measured by real-time qualitative PCR/quantitative PCR, (overall and by bacterial species,) are computed with 95% confidence intervals. The numerator is the number of sputum samples positive for a given pathogen and the denominator is the number of visits with a sputum sample tested for a given pathogen. The bacterial pathogens include H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus, P. aeruginosa and S. pyogenes. A confirmed stable visit is defined as a scheduled study visit for which the investigator confirms that the subject is stable / has recovered from a previous exacerbation.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples in a Given Category Relative to All Combinations for Each Bacterial Pathogen, When Identified by Bacteriological Methods or PCR, at Any Visit
Concordance between bacteriological methods (culture) and PCR sputum results are described for all the combinations of bacterial presence by both measures. Each category name includes the following parameters: Bacteria species-Culture (yes/no)- PCR (yes/no). Concordance is expressed as the number of sputum samples in a given category among the total number of sputum samples assessed for the presence of bacterial pathogens by both culture and PCR
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by Bacteriological Methods, and Classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade
Number of sputum samples obtained at each confirmed stable visit, and positive for bacterial pathogens by bacteriological methods (overall and by bacterial species). The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades [GOLD, 2013]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 < 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 < 50% predicted; GOLD 4 (Very Severe) = FEV1 < 30% predicted.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD Grade
Number of sputum samples obtained at each confirmed stable visit, and positive for bacterial pathogens by PCR (overall and by bacterial species). The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades [GOLD, 2013]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 < 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 < 50% predicted; GOLD 4 (Very Severe) = FEV1 < 30% predicted.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD Grade
Number of sputum samples obtained at each confirmed stable visit, and positive for virus pathogens by PCR (overall and by viral species). The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades [GOLD, 2013]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 < 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 < 50% predicted; GOLD 4 (Very Severe) = FEV1 < 30% predicted.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by Bacteriological Methods and Classified by Severity of AECOPD
Number of sputum samples obtained at each AECOPD visit, and positive for bacterial pathogens by bacteriological methods (overall and by bacterial species). Classification of severity of AECOPD as follows: Mild = controlled with an increase in dosage of regular medications; Moderate = requires treatment with systemic corticosteroids and/or antibiotics; Severe = requires hospitalization.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD
Number of sputum samples obtained at each AECOPD visit, and positive for bacterial pathogens by PCR (overall and by bacterial species). Classification of severity of AECOPD is as follows: Mild = controlled with an increase in dosage of regular medications; Moderate = requires treatment with systemic corticosteroids and/or antibiotics; Severe = requires hospitalization.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD
Number of sputum samples obtained at each AECOPD visit, and positive for viral pathogens by PCR (overall and by viral species). Classification of severity of AECOPD is as follows: Mild = controlled with an increase in dosage of regular medications; Moderate = requires treatment with systemic corticosteroids and/or antibiotics; Severe = requires hospitalization.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Incidence Rate (Per Subject Per Year) of Confirmed and Confirmed Plus Potential AECOPDs, Overall and by GOLD Grade
Incidence rate is estimated by the mean number of exacerbations per subject and per year from Negative Binomial model (or Poisson model in case of under dispersion) without covariates and computed with 95% confidence intervals (CI). Confirmed AECOPDs include AECOPD events plus missed AECOPD events (i.e.: all morning alerts confirmed by phone call (as well as cases with no morning alert) for which there has been no site visit but for which AECOPD medical records are available). Potential AECOPDs include all morning alert confirmed by phone call for which there has been no site visit and for which no medical records are available.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by Severity of AECOPD
Classification of severity of AECOPD is as follows: Mild- Controlled AECOPD with an increase in dosage of regular medications; Moderate- Requires treatment with systemic corticosteroids and/ or antibiotics; Severe- Requires hospitalisation.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by GOLD Grade
The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades [GOLD, 2013]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 < 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 < 50% predicted; GOLD 4 (Very Severe) = FEV1 < 30% predicted.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Days of AECOPD Episodes, Overall and by AECOPD Severity
Descriptive statistics (mean, standard deviation) on the number of days of AECOPD episodes are presented, overall and by AECOPD severity.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
COPD Assessment Test (CAT) Score in Stable COPD Patients
The CAT is a patient-completed instrument to assess the heath-related quality of life (HRQOL) and symptom burden in patients with COPD. Descriptive statistics (mean, standard deviation) on the CAT scores are tabulated at each stable visit. The CAT index is derived as the sum of the ratings recorded for each of the eight individual items. Each of these items has 6 possible scores (0, 1, 2, 3, 4 or 5), leading to a range of 0 (best score) to 40 (worst score) for CAT score.
Measured: At Month 0, Month 6 and Month 12
CAT Score by Frequency of Exacerbations
The CAT is a patient-completed instrument to assess the HRQOL and symptom burden in patients with COPD. Descriptive statistics (mean, standard deviation) on the CAT scores are tabulated by frequency of exacerbations). The CAT index is derived as the sum of the ratings recorded for each of the eight individual items. Each of these items has 6 possible scores (0, 1, 2, 3, 4 or 5), leading to a range of 0 (best score) to 40 (worst score) for CAT score.
Measured: Over the course of one year from the study start: (Month 0 to Month 12)
St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score in Stable COPD Patients
The SGRQ-C is designed to assess HRQOL and current health of the patients. Descriptive statistics (mean, standard deviation) on the SGRQ-C scores are tabulated at each stable visit. The SGRQ-C total score is derived as the weighted sum of the forty individual items leading to a range of 0 (best score) to 100 (worst score) as detailed in the reference manual [St George's Respiratory Questionnaire for COPD patients, version 1.3, 2016].
Measured: At Month 0, Month 6 and Month 12
Post-bronchodilator FEV1 Percentage of Predicted Normal Value in Stable COPD Patients
Summary statistics (mean, standard deviation) on post bronchodilator FEV1% of predicted normal value is tabulated at enrolment and final visit.
Measured: At Pre-Month 0 (screening visit) and Month 12.
Number of Patients With Healthcare Utilisation During Stable Periods
Healthcare utilization includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations. The impact of AECOPD on healthcare utilization is assessed during the stable periods. Hospitalizations that were associated with the disease being studied were not collected as Adverse Events (AEs) or as serious AEs (SAEs) as per protocol.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Number of Patients With Healthcare Utilisation During Exacerbation Periods
Healthcare utilization includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations. The impact of AECOPD on healthcare utilization is assessed during exacerbation periods. Hospitalizations that were associated with the disease being studied were not collected as AEs or as SAEs as per protocol.
Measured: Over the course of one year from the study start (Month 0 to Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start25 Aug 2017
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151395
- Sponsor's protocol ID
- 201112
- Status last verified
- May 2021
- First submitted
- 5 May 2017
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taddei L, Malvisi L, Hui DS, Malvaux L, Samoro RZ, Lee SH, Yeung YC, Liu YC, Arora AK. Airway pathogens detected in stable and exacerbated COPD in patients in Asia-Pacific. ERJ Open Res. 2022 Sep 26;8(3):00057-2022. doi: 10.1183/23120541.00057-2022. eCollection 2022 Jul.
PubMed 36171985
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific
- ClinicalTrials.gov ID
- NCT03151395
- Acronym / sponsor ID
- 201112
- Conditions
- Respiratory Disorders
- Keywords
- COPD, AECOPD, GOLD (Global Initiative for Chronic Obstructive Lung Disease), Asia Pacific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.
Detailed description
The protocol has been amended to implement the following changes:
- Alignment of the protocol to the updated GOLD consensus report of 2017 and the COPD fact sheet.
- Alignment of the study endpoints to the study objectives.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Group | Other | Other: Sputum and blood samplingModerate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic Diary Card, sputum sampling, pre- and post-bronchodilator spirometry, return for follow-up visits).
- Written informed consent obtained from the subject.
- Male or female aged 40 years or older at the time of enrolment.
- Confirmed diagnosis of moderate to very severe COPD based on post-bronchodilator spirometry (i.e. forced expiratory volume in 1 second [FEV1] over forced vital capacity [FVC] ratio [FEV1/ FVC] < 0.7 and FEV1 < 80% predicted [GOLD grades 2, 3 and 4].
- Stable COPD patient* with documented history** (e.g. medical record verification) of at least 1 moderate or severe AECOPD within the 12 months before study entry.
Key exclusion criteria (12 listed)
- Diagnosed with a respiratory disorder other than COPD (such as sarcoidosis, active tuberculosis or receiving tuberculosis treatment, clinically significant bronchiectasis, lung fibrosis, pulmonary embolism, pneumothorax, lung cancer diagnosed within the previous 5 years, current primary diagnosis of asthma in the opinion of the investigator), or chest X-ray revealing evidence of clinically significant abnormalities not believed to be due to the presence of COPD*. Subjects with allergic rhinitis do not need to be excluded and may be enrolled at the discretion of the investigator.
- Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.
- Undergone or has had lung surgery 12 months before, or plans to have lung surgery 12 months after, study entry.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Received chemotherapy within the 12 months before study entry.
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 |
|---|---|---|
| Sputum and blood samplingEvaluation of the occurrence of potential bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. | Other | Total Group |
Primary outcome
Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDs
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
The proportion of sputum samples obtained at each visit (confirmed stable or AECOPD visits) and positive for specific bacterial pathogens by bacteriological methods (overall and by bacterial species). Numerator is the number of sputum samples positive for a given pathogen and denominator is the number of visits with a sputum sample tested for a given pathogen. Proportion is computed with 95% confidence intervals. A confirmed stable visit is defined as a scheduled study visit for which the investigator confirms that the subject is stable/ has recovered from a previous exacerbation. Bacterial pathogens include Haemophilus influenzae (Hi), Non-typeable Haemophilus influenzae (NTHi), non-Haemophilus influenzae (Non-Hi), Moraxella catarrhalis (M. catarrhalis), Streptococcus pneumoniae (S. pneumoniae), Staphylococcus aureus (S. aureus), Pseudomonas aeruginosa (P. aeruginosa), Klebsiella pneumoniae (K. pseumoniae), Acinetobacter baumannii (A. baumannii).
Percentage of Sputum Samples Positive for Viral Pathogens as Identified by Polymerase Chain Reaction (PCR) in Stable COPD Patients and During AECOPDs
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
The proportion of sputum samples obtained at each visit (confirmed stable visits and AECOPD visits) and positive for specific viral pathogens by PCR (overall and by viral species). The numerator is the number of sputum samples positive for a given pathogen and the denominator is the number of visits with a sputum sample tested for a given pathogen. The proportion is calculated with 95% confidence intervals. Viral pathogens, as identified by PCR, include respiratory syncytial virus (RSV), parainfluenza virus, enterovirus, human rhinovirus (HRV), metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus.
18 secondary outcomes
Percentage of Sputum Samples Positive for Bacterial Pathogens in Stable COPD Patients and During AECOPDs, as Identified by PCR
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples in a Given Category Relative to All Combinations for Each Bacterial Pathogen, When Identified by Bacteriological Methods or PCR, at Any Visit
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by Bacteriological Methods, and Classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD Grade
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD Grade
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by Bacteriological Methods and Classified by Severity of AECOPD
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Incidence Rate (Per Subject Per Year) of Confirmed and Confirmed Plus Potential AECOPDs, Overall and by GOLD Grade
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by Severity of AECOPD
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by GOLD Grade
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Days of AECOPD Episodes, Overall and by AECOPD Severity
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
COPD Assessment Test (CAT) Score in Stable COPD Patients
Time frame: At Month 0, Month 6 and Month 12
CAT Score by Frequency of Exacerbations
Time frame: Over the course of one year from the study start: (Month 0 to Month 12)
St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score in Stable COPD Patients
Time frame: At Month 0, Month 6 and Month 12
Post-bronchodilator FEV1 Percentage of Predicted Normal Value in Stable COPD Patients
Time frame: At Pre-Month 0 (screening visit) and Month 12.
Number of Patients With Healthcare Utilisation During Stable Periods
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Number of Patients With Healthcare Utilisation During Exacerbation Periods
Time frame: Over the course of one year from the study start (Month 0 to Month 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36171985Taddei L, Malvisi L, Hui DS, Malvaux L, Samoro RZ, Lee SH, Yeung YC, Liu YC, Arora AK. Airway pathogens detected in stable and exacerbated COPD in patients in Asia-Pacific. ERJ Open Res. 2022 Sep 26;8(3):00057-2022. doi: 10.1183/23120541.00057-2022. eCollection 2022 Jul.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sputum and blood sampling in people with Respiratory Disorders, run by GlaxoSmithKline at 19 sites in 4 countries.
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 9 inclusion and 12 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Taiwan, Philippines, South Korea, 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?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDs (time frame: Over the course of one year from the study start (Month 0 to Month 12)). The study lists 2 primary outcomes in all. 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 NCT03151395, 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 14 Jun 2021.