Use of Diagnostic Measures (Including Blood Eosinophil Counts) and Their Impact on Lung Specialists' Treatment Decisions in Patients With COPD in Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Number of physician reported rationale for choice of diagnostic test
研究概览
简要总结
This study will evaluate the diagnostic measures (including blood eosinophil counts) commonly used by lung specialist's in routine clinical care of subjects with COPD in Germany and how these diagnostic tests influence the physician's treatment decisions. The study will be conducted in three parts. In the first part, lung specialist's, who will not participate in the survey, will develop doctor's questionnaire. The second part is an interventional cross-sectional study, wherein approximately 30 lung specialists will be enrolled and data on their perspective on diagnosis and treatment of COPD subjects will be collected via the revised doctor's questionnaire. The third part is a retrospective non-interventional study where each doctor will collect retrospective data from selected subjects with COPD from the time of informed consent up to 12 months before. The retrospective data will be collected from subject files of approximately 250 subjects with COPD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •For participating centers (Sample 1: 30 lung specialists from Germany)
- •More than 10 years of experience in respiratory medicine
- •At least 500 subjects under supervision in hospital- or office-based setting: a) Focus on obstructive lung diseases. b) Board certification. c) Informed consent to participate in this study and to share files of consenting subjects.
- •For subjects (Sample 2: 250 COPD subjects from these 30 doctors from sample 1)
- •Written informed consent to use his/her data.
- •Age >=40 years
- •Pack years >10, current or former smoking
- •Duration of COPD: >=1 year since COPD diagnosis record in subject files (also confirmed by spirometry)
- •No concurrent asthma diagnosis
- •At least one year of documented disease history at participating study doctors and have to be under the care of the before mentioned physician during this time because of COPD.
排除标准
- •Subjects who are pregnant and breastfeeding (in the last 12 months)
- •Subjects currently participating in any interventional study
- •Subjects with severe comorbidities which would have influence on the COPD therapy
结局指标
主要结局
Number of physician reported rationale for choice of diagnostic test
时间窗: Up to 12 months
The reasons for choice of diagnostic test will be determined from doctor's questionnaires and from medical chart review.
Number of physicians with usage of diagnostic tests in routine clinical practice
时间窗: Up to 12 months
The data on diagnostic test including blood eosinophil count commonly used by lung specialists in routine clinical practice will be obtained from doctor's questionnaire.
次要结局
- Number of physician reported reasons for drug selection(Up to 12 months)
- Number of subjects with use of patient reported outcome (PRO) assessment(Up to 12 months)
- Number of subjects with concomitant diseases(Up to 12 months)
- Number of subjects with a history of respiratory medication(Up to 12 months)
- Number of subjects receiving immunosuppressive treatment(Up to 12 months)
- Number of subjects receiving oral corticosteroids (OCS) for exacerbations(Up to 12 months)
- Number of subjects receiving allergic treatment(Up to 12 months)
- Number of subjects receiving any COPD medication(Up to 12 months)
- Number of subjects with emergency room visits related to COPD(Up to 12 months)
- Number of physician reported reasons for blood eosinophil test selection(Up to 12 months)
- Number of subjects receiving COPD maintenance treatment(Up to 12 months)
- Number of subjects with hospitalization for COPD(Up to 12 months)
- Number of subjects with use of other diagnostic measures(Up to 12 months)
- Number of subjects receiving current medication(Up to 12 months)
- Number of subjects with use of antibiotics(Up to 12 months)
- Number of subjects with history of exacerbations(Up to 12 months)