Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- asthma control 1
研究概览
简要总结
Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages.
详细描述
Multiple sensitizations but also blood eosinophilia are associated with the persistence of exacerbations during childhood. The pivotal role of eosinophilia in the pathophysiology of allergic asthma and more generally of severe asthma in the pediatric population has made it an important research topic for many years. The indirect demonstration of bronchial inflammation by analyzing blood eosinophilia is common practice, especially when monitoring the effectiveness of biotherapies. However, blood eosinophilia is not always clearly related to bronchial eosinophilia.
On the other hand, several teams have recently sought to highlight the recurrence of allergen sensitization profiles associated with severe asthma, in order to identify predictive factors of clinical evolution.
Finally, recent studies have shown that the nasal microbiota plays an important role in the onset, development and severity of asthma.
Our study will allow us to study the clinical evolution at 10 years of the children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages. These phenotypic trajectories have an important therapeutic implication, leading to the prescription of personalized treatments, in particular biologics (monoclonal antibodies).
Primary objective To evaluate, in children with moderate to severe asthma, the control of asthma according to the therapeutic load, atopic pathologies during childhood and initial serum levels of blood eosinophils and biomarkers of eosinophil activation Secondary objective Evaluate the evolution of asthma phenotypes according to the associated atopic pathologies (allergic rhinitis, atopic dermatitis and food allergy), according to the number of atopic comorbidities and their severity.
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
- •absence of opposition from the legal representative of the patient and if possible from the patient himself.
- •patient with moderate to severe asthma at preschool or school age, previously included in SAMP Cohort
排除标准
- •Patient included in another clinical study.
- •Lack of coverage by social security.
结局指标
主要结局
asthma control 1
时间窗: through study completion, 4 years
Asthma control according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. www.ginasthma.org.)
asthma control 2
时间窗: through study completion, 4 years
Score of the Asthma Control Test (for children \> 11 years old) and of the Asthma Control Test reserved for asthmatic children from 4 to 11 years old (ACT™, © 2002, by QualityMetric Incorporated Asthma France / French Control Test™ is a trademark of QualityMetric Incorporated. www.asthmacontroltest.com)
次要结局
- asthma severity 2(through study completion, 4 years)
- atopic comorbidities 2(through study completion, 4 years)
- atopic comorbidities 3(through study completion, 4 years)
- asthma severity 1(through study completion, 4 years)
- atopic comorbidities 1(through study completion, 4 years)
- nasal and skin microbiota(1 day at inclusion of patient)
