National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Stratification of severe asthmatics in 3 phenotypes
研究概览
简要总结
The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. Moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. It is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in RAMSES a national severe asthma cohort and future research tracks of this cohort.
详细描述
The Th2 phenotype corresponds to severe asthmatic patients eligible for new subcutaneous targeted asthma therapies, which can bring about a real improvement in symptoms and quality of life. No data are available on the proportion of this patient population since the advent of biotherapies, as well as the impact on quality of life and pathway by phenotype.
The survey will be conducted using a collection of data on a dedicated questionnaire including validated questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.
The objectives of the survey are to estimate the phenotypic profile distribution of severe asthmatic patients and the proportion currently treated by biotherapies as well as the impact of the pathology on the clinical profile and quality of life of patients with severe asthma.
Investigative pulmonologists selected from university or general hospitals or from private practice will propose to their eligible patients to participate in the study. Patients informed and not opposed to participating will complete, at the end of the consultation, the dedicated questionnaire pre-filled by the pulmonologist (for the medical data required for phenotypic stratification). The questionnaires will be collected from the centers and the data centralized to establish the database. Analyzes will be done in order to stratify the populations according to their phenotype and to analyze the data globally and by subgroup.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of severe asthma for at least 12 months confirmed by a respiratory physicians and meeting the ATS / ERS definition,
- •Social insured patient,
- •Patient given the non-opposition
排除标准
- •Patient participating in a therapeutic clinical trial
- •Patient opposing participation in this study
- •Patient with reading and comprehension difficulties not allowing him to complete the questionnaires
结局指标
主要结局
Stratification of severe asthmatics in 3 phenotypes
时间窗: 12 months
The severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype
次要结局
未报告次要终点