Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,741
- 试验地点
- 22
- 主要终点
- Change from baseline in BODE-Score at 18 months
研究概览
简要总结
The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients.
Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.
详细描述
Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40 years and older
- •diagnosis of COPD (GOLD-Criteria) or chronic bronchitis
- •informed consent
- •available for repeated study visits pver 18 months
排除标准
- •having undergone big lung surgery (e.g. lung reduction, lung transplant)
- •Moderate or severe exacerbation within the last 4 weeks
- •having a lung tumor
- •Unable to walk or to understand the intention of the project
结局指标
主要结局
Change from baseline in BODE-Score at 18 months
时间窗: at initial visite, after 18, 36, 54, 72, 90 and 108 months
The BODE-Score comprises BMI, airway obstruction, dyspnea and exercise capacity and is a good predictor for death in COPD patients. Progression is defined as a change in BODE-score by \>=1 point over the observation period.
次要结局
- COPD related hospitalization(after 18, 36, 54, 72, 90 and 108 months)
- COPD related mortality(after 18 months)
研究者
Claus Vogelmeier
Prof. Dr.
Philipps University Marburg Medical Center