Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 20
- 主要终点
- Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDs
时间窗: 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
时间窗: 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.
次要结局
- 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 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 Viral Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD(Over the course of one year from the study start (Month 0 to Month 12))
- 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 Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by Bacteriological Methods and Classified by Severity of AECOPD(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(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 Subjects With AECOPDs, Classified by Number of Exacerbations and by GOLD Grade(Over the course of one year from the study start (Month 0 to Month 12))
- COPD Assessment Test (CAT) Score in Stable COPD Patients(At Month 0, Month 6 and 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))
- Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by Severity of AECOPD(Over the course of one year from the study start (Month 0 to Month 12))
- CAT Score by Frequency of Exacerbations(Over the course of one year from the study start: (Month 0 to Month 12))
- Number of Patients With Healthcare Utilisation During Exacerbation Periods(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(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(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(At Month 0, Month 6 and Month 12)
- Number of Patients With Healthcare Utilisation During Stable Periods(Over the course of one year from the study start (Month 0 to Month 12))
- Post-bronchodilator FEV1 Percentage of Predicted Normal Value in Stable COPD Patients(At Pre-Month 0 (screening visit) and Month 12.)