A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number of subjects who self-reported physician diagnosis of COPD
研究概览
简要总结
Early diagnosis and appropriate treatment for COPD subjects are both critical to minimize the progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil (specific type of white blood cell that protects body against certain kinds of germs) level is associated with increased risk of both moderate and severe exacerbations in COPD subjects. To date, there is insufficient amount of data that describes the prevalence of COPD in Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five centers located in five different Brazilian cities will provide estimation about the prevalence of COPD in primary care and will also determine the levels of eosinophils in subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to be enrolled in the study.
详细描述
The study is a cross sectional (prevalence study).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult >= 35 years old
- •At least one of the following risk factors for COPD:
- •being a current smoker (who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) or past smoker (who has smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview); Current or past exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure >=100 hours/year
- •Capable of giving signed informed consent
排除标准
- •Physical or mental disability to complete the study procedures
- •Heart above 120 beats per minute
- •Participants under treatment for tuberculosis
- •Participant in current clinical trial
- •Pregnancy
- •Patients with one of the following contraindications to spirometry: chest surgery in the last month; abdominal surgery within the past three months; neuromuscular disease, acute coronary syndrome; retinal detachment; hospitalization for any cardiac problem in the prior 3 months.
结局指标
主要结局
Number of subjects who self-reported physician diagnosis of COPD
时间窗: Day 1
Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.
Number of subjects with under diagnosed COPD
时间窗: Day 1
Number of subjects who meet the spirometry confirmed criteria of COPD (post-BD FEV1/FVC\<0.7) but do not self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.
Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria
时间窗: Day 1
Spirometry confirmed COPD diagnosis according to fixed ratio criteria will be defined as those with post-Bronchodilatador (BD) Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) \< 0.7 among the total of patients with valid spirometry. Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 microgram (mcg) Salbutamol.
Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria
时间窗: Day 1
Spirometry confirmed COPD diagnosis according to Lower limit of normal (LNN) criteria will be defined as those with lower 5th percentile for predicted post-BD FEV1/FVC Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 mcg Salbutamol.
Number of subjects with misdiagnosed COPD
时间窗: Day 1
Number of subjects who do not meet the spirometry confirmed criteria of COPD but self-report diagnosis of emphysema, chronic bronchitis, or COPD.
Number of subjects with physician COPD diagnosis
时间窗: Day 1
Number of subjects who meet the spirometry confirmed criteria of COPD(post-BD FEV1/FVC\<0.7) and self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.
次要结局
- Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups(Day 1)
- Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups(Day 1)
- Mean Charlson Comorbidity Index (CCI) score(Day 1)
- Descriptive statistics for COPD Assessment Test (CAT) score(Day 1)
- Number of subjects moderate exacerbation(Day 1)
- Number of subjects with severe exacerbation(Day 1)
- Descriptive statistics for FEV1(Day 1)
- Mean CCI score as a measure of clinical characteristics by ACO definitions(Day 1)
- Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions(Day 1)
- Number of subjects with severe exacerbation by ACO definition(Day 1)
- Number of subjects with mild exacerbation(Day 1)
- Assessment of treatment used in the last 14 days and an last year(Day 1)
- Type of access to treatment(Day 1)
- Number of subjects with Asthma-COPD Overlap (ACO)(Day 1)
- Descriptive statistics for blood eosinophil's concentration(Day 1)
- Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter(Day 1)
- Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions(Day 1)
- Number of subjects with moderate exacerbation by ACO definition(Day 1)
- Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups(Day 1)
- Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups(Day 1)
- Number of subjects with mild exacerbation of eosinophil groups(Day 1)
- Number of subjects with moderate exacerbation of eosinophil groups(Day 1)
- Number of subjects with mild exacerbation by ACO definition(Day 1)
- Mean CCI score as a measure of clinical characteristics of eosinophil groups(Day 1)
- Number of subjects with severe exacerbation of eosinophil groups(Day 1)