Klinisches Register Schweres Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,500
- 试验地点
- 45
- 主要终点
- Symptom Control
研究概览
简要总结
The German Asthma Net e.V. focusses on science and research in patients with severe asthma. This includes, in particular, the optimization of medical care and treatment for patients with severe asthma as well as the elucidation and information. An unavoidable basis for a better understanding of severe asthma is the registration and comprehensive characterization of a large patient population. To date, there are only few reliable data on incidence, prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the German Asthma Net e.V. was established in December 2011 as a clinical registry for patients with severe asthma, initially set up on a national basis.
详细描述
Sociodemographic parameters (e.g., gender, date of birth) and medical parameters (diagnosis, therapy) are entered in the register. In addition, data on lung function, laboratory values (IgE and eosinophil granulocytes), asthma control (symptoms, nocturnal awakenings, on-demand medication, exacerbations), smoking status, and concomitant therapy (inhalable corticosteroids, bronchodilators, and systemic steroids) are collected. This information will be collected at the baseline visit, and then once a year at a follow up visit, for fifteen years.
Participants will be assigned a unique study ID to protect the confidentiality of their personal health care information. Personal data and register data are on separate servers and thus meet the requirements of data protection.
The primary purpose is to establish a clinical registry for patients with severe asthma. The number of patients with severe asthma at a single center or practice is usually small, so several centers (clinics and practices) in Germany have joined together to form the German Asthma Net e.V. to optimize the diagnostic evaluation and treatment of patients with severe asthma.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Symptom Control
时间窗: Baseline, four months, yearly for up to 15 years
Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
次要结局
- Asthma Control Questionnaire(Baseline, yearly for up to 15 years)
- Fraction of exhaled nitric oxide (FeNo)(Baseline, 4 months, yearly for up to 15 years)
- Eosinophilic granulocytes(Baseline, 4 months, yearly for up to 15 years)
- Exacerbations(Baseline, four months, yearly for up to 15 years)
- Utilization of the health care system(Baseline, yearly for up to 15 years)
- Quality of Life Questionnaire(Baseline, yearly for up to 15 years)
- Symptoms and health-related quality of life(Baseline, yearly for up to 15 years)
- Neutrophilic granulocytes(Baseline, 4 months, yearly for up to 15 years)
- CO diffusion capacity(Baseline, yearly for up to 15 years)
- Forced Vital Capacity (FVC)(Baseline, 4 months, yearly for up to 15 years)
- Changes in dose in mg(4 months, yearly for up to 15 years)
- Forced Exhaled Volume in 1 second (FEV1)(Baseline, 4 months, yearly for up to 15 years)
- Changes in medication(Baseline, 4 months, yearly for up to 15 years)
- Blood Gas analysis(Baseline, 4 months, yearly for up to 15 years)
- Leucocytes(Baseline, 4 months, yearly for up to 15 years)