Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 693
- 试验地点
- 13
- 主要终点
- Incidence of hospitalizations
研究概览
简要总结
Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.
详细描述
This is a prospective multicentre cohort, non-interventional study. The design is to have multiple medical centres representing the regions of Brazil. Each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. There are also some inferred genetic differences due to previous colonization and miscegenation. *CAT (COPD Assessment Test) OU CAAT (Chronic Airway Assesment Test) poderão ser usados intercambiavelmente. The patients will be enrolled in non-random consecutive method and will be followed up for 12 months.
There will be on-site visits at inclusion (V0), 6 and 12 months. There will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation.
There will be 8 participating centres in Brazil, representing all 5 regions (North, Northeast, Midwest, Southeast and South). They will be Teaching Hospitals, Regional Reference Hospitals, Tertiary Hospitals or High Complexity Hospitals. The data will be collected on each site and will be adjudicated by the ARO Team.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, aged 18 years or older, with confirmed COPD according to GOLD 2024: previous or current exposure and spirometry (FEV1/FVC =2 or CAT >=10); or
- •GOLD E (>=2 moderate or 1 severe exacerbation - hospitalization); or
- •GOLD 3 and 4 (FEV1 <50%).
排除标准
- •Advanced fibrosing interstitial lung disease (extent >=50%); and/or
- •High-risk pulmonary hypertension (on triple therapy); and/or
- •Active cancer - on systemic therapy
结局指标
主要结局
Incidence of hospitalizations
时间窗: through study completion, an average of 1 year
Any need for hospitalization involving a hospital stay of more than 24 hours
Incidence of exacerbations
时间窗: through study completion, an average of 1 year
This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration
Incidence of Mortality
时间窗: through study completion, an average of 1 year
All deaths will be reviewed, determining the main cause of the fatal outcome.
次要结局
- Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD(through study completion, an average of 1 year)
- Incidence of lung neoplasia(through study completion, an average of 1 year)