Inflammatory and Immune Profiles at the Time of a Severe Exacerbation in Preschool Asthmatic Children (<5 Years), According to the Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 主要终点
- Inflammatory profile at exacerbation
研究概览
简要总结
Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years).
Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW), absence of symptoms between exacerbations, among which Severe Intermittent Wheeze (SIW); and Multiple-trigger wheeze (MTW). The determinants of these different clinical phenotypes and their evolution have been poorly studied.
The purpose of this study is to assess preschool wheezers at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories
详细描述
Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years).
Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW): wheezing during discrete time periods (exacerbations), absence of symptoms between exacerbations; among which Severe Intermittent Wheeze (SIW): EVW with ≥ 2 exacerbations over the last 6 months; and Multiple-trigger wheeze (MTW): wheezing during exacerbations but also symptoms (cough, exercise-induced symptoms,…) between episodes. The determinants of these different clinical phenotypes and their evolution have been poorly studied.
The purpose of this study is to assess preschool asthmatic children at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories.
The primary objective is to compare levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum between the 2 main phenotypes: EVW and MTW.
Preschool asthmatic children hospitalized for a severe exacerbation (requiring a course of systemic steroids) are included in a pediatric ward of one of the hospitals involved in the study, in the Hauts-de-France Region, France.
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschool children aged 1 to < 5 years
- •Asthmatic / recurrent wheezers (≥ 3 discrete exacerbations since birth and/or symptoms between exacerbations, according to the definition from the French HAS and GINA guidelines)
- •Hospitalized (less than 3 days ago) for a severe exacerbation (requiring a course of oral steroids)
- •In a pediatric ward participating in the study (Hospital centers of Lille, Arras, Bethune, Douai, Lens, Roubaix, Tourcoing, Armentieres, Seclin)
- •Parental consent
排除标准
- •History of chronic disease (other than asthma)
- •History of preterm birth (inf 36 weeks of amenorrhea)
- •Lack of understanding from the parents
结局指标
主要结局
Inflammatory profile at exacerbation
时间窗: At the time of the inclusion
concentration levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
次要结局
- Levels of cytokines in blood(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Levels of interferons in blood(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Levels of interferons in induced sputum(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Percentage of patients with associated atopic diseases(At the time of the inclusion)
- Features of the exacerbation: severity(At the time of the inclusion)
- Blood leukocyte count(At the time of the inclusion and at the age of 7)
- History at the age of 7(At the age of 7)
- Inflammatory profile at steady state(at baseline: consult at least 8 weeks after exacerbation)
- Levels of chemokines in blood(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Change of inflammatory profile between exacerbation and steady state(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Percentage of patients with tobacco exposure(At the time of the inclusion)
- Microbiological phenotype: viral status(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Control of asthma at the age of 7(At the age of 7)
- Levels of cytokines in induced sputum(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Expression patterns of mononuclear cells(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Percentage of patients with mould/moisture exposure(At the time of the inclusion)
- Control of asthma(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Atopy(At the time of the inclusion and at the age of 7)
- Levels of chemokines in induced sputum(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Percentage of patients living in urban area(At the time of the inclusion)
- number of asthma exacerbations in the previous year(At the time of the inclusion)
- ImmunoCAP ISAC (Thermo Fisher Scientific)(At the time of the inclusion and at the age of 7)
- Lung function at the age of 7: forced expiratory volume in one second(At the age of 7)
- Percentage of patients with pet ownership(At the time of the inclusion)
- Features of the exacerbation: length(At the time of the inclusion)
- Microbiological phenotype: bacteriological status(At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation))
- Atopy at the age of 7(At the age of 7)
- Lung function at the age of 7 : forced vital capacity(At the age of 7)