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

NCT ID: NCT03151395

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-25
• Study Completion Date: 2020-04-06

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Total Group

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

Group Type: OTHER

Sputum and blood sampling

Intervention Type: OTHER

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

Interventions

Sputum and blood sampling

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Kowloon, , Hong Kong

GSK Investigational Site

Lai Chi Kok, , Hong Kong

GSK Investigational Site

Shatin, , Hong Kong

GSK Investigational Site

Iloilo City, , Philippines

GSK Investigational Site

Jaro, Iloilo City, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Marilao, Bulacan, , Philippines

GSK Investigational Site

Bucheon-si, , South Korea

GSK Investigational Site

Gangwon-do, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Changhua, , Taiwan

GSK Investigational Site

Keelung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

Countries

Hong Kong; Philippines; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 36171985 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

201112

Identifier Type: -

Identifier Source: org_study_id