Prevalence of Comorbidities of COPD in the Exacerbator Phenotype - A Cross Sectional Disease/Condition Focused Observational Study on COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 860
- 主要终点
- Prevalence of Comorbidities
研究概览
简要总结
The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.
详细描述
This is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. No additional study medication will be administered. This study will enroll patients who have been previously diagnosed with COPD. This study will look at the medical history and other diseases that have been diagnosed in people who also have COPD.
The study will enroll approximately 3000 patients.
This multi-centre trial will be conducted in Italy. The overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. There will not be any follow up assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-85, of either gender.
- •Signed informed consent.
- •Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction.
- •Forced Expired Volume measured after 1 second expiration (FEV-1) < 50% in a previous test (no time limits).
- •Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits.
- •On treatment of bronchodilators (no restrictions) for the last 12 months at least.
- •History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit.
排除标准
- 未提供
结局指标
主要结局
Prevalence of Comorbidities
时间窗: Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit
The following comorbidities were accounted for (from the patient records): arterial hypertension, ischemic heart disease, other cardiac disorders, arrhythmia, congestive heart failure, diabetes, metabolic syndrome, known osteoporosis, depression, and chronic renal insufficiency.
Percentage of Participants having Annual Spirometric Tests
时间窗: 12 months prior and up to the Study Index Visit
次要结局
未报告次要终点