Contribution of Infectious Pathogens to Acute Respiratory Illness in Adults and Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)
研究概览
简要总结
The aim of this study is to generate epidemiological data to further explore determinants of Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral pathogens to Acute Exacerbation of COPD (AECOPD) episodes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Male or female subjects between, and including, 40 and 85 years of age, at the time of consent.
- •Subjects with confirmed diagnosis of COPD with Forced Expiratory Volume of air expired in 1 second (FEV1) of </=80% of predicted normal and FEV1/Forced expiratory Vital Capacity (FVC)<0.7
- •Subjects have moderate, severe, or very severe COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging.
- •Subjects have a current or prior history of >/=10 pack-years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
- •Subjects present a documented history of >/=1 exacerbation requiring antibiotics and/or oral corticosteroids or hospitalization in the previous 12 months.
排除标准
- •Subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders.
- •Subjects having undergone lung surgery.
- •Subject has a α-1 antitrypsin deficiency as underlying cause of COPD.
- •Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids.
- •Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit.
- •Subject has other conditions that the principal investigator judges may interfere with the study findings. Women who are pregnant or lactating or are planning on becoming pregnant during the study.
研究组 & 干预措施
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: Blood sample (Procedure)
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: Sputum sample (Procedure)
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: Nasopharyngeal swab (Procedure)
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: Urine sample (Procedure)
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: End tidal breath sample (Procedure)
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: Data collection (Other)
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
干预措施: Tests (Other)
结局指标
主要结局
Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)
时间窗: During year 1
An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD The Means and Confidence Intervals (CI) were estimated using the Negative Binomial model taking into account time to follow up. Estimated exacerbations were presented as mean number of exacerbations per (/) subject/ year.
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
时间窗: During Year 1
Bacterial pathogens assessed were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Steptococcus pneumoniae (Sp), Staphylococcus Aureus (Sta), Pseudomonas aeruginosa (Psa), any or other. For each bacteria, the means and CIs were estimated from Negative Binomial model taking into account the follow up time.Estimated exacerbations were presented as mean number of exacerbations/ subject/ year.
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
时间窗: During Year 1
Bacterial pathogens assessed, by culture, were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Streptococcus pneumoniae (Sp), Staphylococcus aureus (Sta), Pseudomonas aeruginosa (Psa), any bacteria or other bacteria. Overall exacerbation rate is the average number of exacerbations for each subject during their time in the study.
次要结局
- Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit(During Year 1)
- Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit(During Year 1)
- Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit(During Year 1)
- Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum(During Year 1)
- Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp(During Year 1)
- Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria(During Year 1)
- Mean Number of Days Between 2 Consecutive AECOPDs(During Year 1)
- Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi(During Year 1)
- Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit(During Year 1)
- Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal(During Year 1)
- Number of Subjects Receiving Various Health Care Types During AECOPD(During Year 1)
- AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay(During Year 1)
- AECOPD Rate With Overall and Specific Viral Pathogens in Sputum(During Year 1)
- Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum(During Year 1)
- Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum(During Year 1)
- AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity(During Year 1)