The Italian COPD Registry. The DescribinG bUrden of COPD and Occurrence of mortaLity in a Cohort of Italian Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact.
The present real life study is aimed at describing the clinical and functional characteristics, treatment patterns, impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD.
详细描述
The temporal relationship of observation period to time of participant enrollment will be both retrospective and prospective.
A digital dataset will be shared with the participating centers. The following variables, if available, will be collected.
Demographic and clinical variables:
- Age, sex, height, weight, BMI, waist circumference.
- Pneumonia episodes in the last 12 months and number of hospitalizations for pneumonia.
- Number of pulmonary rehabilitation cycles performed
- Vaccination status (Flu, SARS-CoV-2, pneumococcus, human respiratory syncytial virus, herpes zoster)
COPD characteristics:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •established diagnosis of COPD (defined as age ≥ 40 years old, smoking history ≤ 20 pack years, postbronchodilator forced expiratory volume in one second to slow vital capacity ratio (FEV1/VC) ≤ the lower limit of normal (LLN) criteria.
排除标准
- •Presence of current clinically significant asthma
- •Diagnosis or clinically significant alternative respiratory diseases (such as interstitial lung disease or bronchiectasis)
研究组 & 干预措施
COPD patients
All patients with a functionally confirmed diagnosis of COPD
干预措施: Pharmacological treatment (Other)
结局指标
主要结局
All cause mortality
时间窗: From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months
Annual all-cause mortality rate
Burden of moderate and severe COPD acute exacerbations
时间窗: From index date (registry inclusion) until the date of first event of moderate or severe exacerbation, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months
Incidence and annual rate of moderate and/or severe exacerbations
次要结局
- Cardiovascular mortality(From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months)
- Cardiovascular comorbidities(At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death)
- Cardiovascular events(From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months)
- Lung function decline(From index date (registry inclusion) until the date of the first lung function test, and any following available lung function assessment, or the date of patient's death, whichever comes first, assessed up to 120 months)
- Eosinophil count(From index date (registry inclusion) until the date of first available eosinophil count, and any following point in time with available eosinophil count updates, or patients' death, whichever comes first, assessed up to 120 months)
- Evaluation of the pharmacological treatment at baseline and treatment switches(From index date (registry inclusion) until the date of first available inhaled treatment switch, and every point in time the patient changes inhaled treatment, or the patient's death from any cause, whichever comes first, assessed up to 120 months)
研究者
Pierachille Santus, MD, PhD
Professor
University of Milan