Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific

NCT03151395 | Completed Results

• 1 other identifier: 201112
• Study Type: interventional
• Target: 197
• Locations: 4 countries
• Sites: 19

Brief 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 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.

Conditions

Respiratory Disorders

Keywords

COPD; AECOPD; GOLD (Global Initiative for Chronic Obstructive Lung Disease); Asia Pacific

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  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

  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

  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

  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

  Over the course of one year from the study start (Month 0 to Month 12)

Study Arms (1)

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

Other: Sputum and blood sampling

Interventions

Sputum and blood sampling OTHER

Evaluation of the occurrence of potential bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD.

Total Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Kowloon, Hong Kong

Location

GSK Investigational Site

Lai Chi Kok, Hong Kong

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Iloilo City, 5000, Philippines

Location

GSK Investigational Site

Jaro, Iloilo City, 5000, Philippines

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Manila, 1014, Philippines

Location

GSK Investigational Site

Marilao, Bulacan, 3019, Philippines

Location

GSK Investigational Site

Bucheon-si, 420-717, South Korea

Location

GSK Investigational Site

Gangwon-do, 26426, South Korea

Location

GSK Investigational Site

Incheon, 403-720, South Korea

Location

GSK Investigational Site

Seoul, 03312, South Korea

Location

GSK Investigational Site

Seoul, 156-755, South Korea

Location

GSK Investigational Site

Changhua, 500, Taiwan

Location

GSK Investigational Site

Keelung, 20401, Taiwan

Location

GSK Investigational Site

Taichung, 40201, Taiwan

Location

GSK Investigational Site

Taichung, 404, Taiwan

Location

GSK Investigational Site

Taichung, 40705, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36171985 DERIVED

MeSH Terms

Conditions

Respiration Disorders; Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 12, 2017
• Study Start: August 25, 2017
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Locations

HK (3); TW (6); PH (5); KR (5)