Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- To estimate the prevalence of severe asthmatic subjects at Spanish sites
研究概览
简要总结
Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity (intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1 in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence of non-controlled severe asthma.
This prospective, non-interventional, observational, multicenter and case-control study aims to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to receive biological treatments approved for this disease, resource consumption and evaluate the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided into two cohorts, based on asthma severity according to the Global Initiative for Asthma (GINA) and the International European Respiratory Society (ERS)/American Thoracic Society (ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic subjects will be enrolled in the study. A software of big data will be used to do a sub study for comparing the results obtained through this software tool against results obtained through Gold standard classical methods used in this prospective observational study (the descriptive assessment of severe asthma prevalence and the prospective evolution of subjects).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（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
To estimate the prevalence of severe asthmatic subjects at Spanish sites
时间窗: Up to 12 months
Assessment will be done based on the type of hospital, department type of hospital or clinic, sources of the service and number of asthmatic subjects diagnosed according to GEMA guidelines.
次要结局
- Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects(Up to 12 months)
- Number of subjects evolved with severe asthma in comparison with non severe asthma at 6 and 12 months(Up to 12 months)
- To assess the social impact of subjects with severe asthma in comparison with non-severe asthmatic subjects in terms of Health Related Quality of Life (HRQoL)(Up to 12 months)
- To compare the software's prediction in the evolution of subjects with severe asthma at 6 and 12 months with the results obtained by monitoring in the observational study(Up to 12 months)
- Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects(Up to 12 months)
- Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma(Up to 12 months)
- To estimate the prevalence of different phenotypes in severe asthma(Up to 12 months)
- To establish the determinant factors clinicians use, to predict subjects evolution(Up to 12 months)
- To compare the prediction in the evolution of subjects with severe asthma at 6 and 12 months, based on the aggregated information collected in the last 5 years previous to the start of the observational study with the prediction done by the physician(Up to 12 months)
- Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline(Up to 12 months)
- To assess the use of healthcare resources (direct and indirect) in subjects with severe asthma and non-severe asthma(Up to 12 months)
- To test if the calculated prevalence using a specific software is similar to the prevalence of severe asthma obtained through monitoring using gold standard(Up to 12 months)
- To predict evolution of subjects with severe and non-severe asthma at month 6 and month 12, based on the physician's experience and knowledge, compared to results obtained through monitoring(Up to 12 months)