The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Pediatric Arm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 5
- 主要终点
- Prevalence of asthma
研究概览
简要总结
Despite its common occurrence, still little is known about pathomechanisms determining different wheeze and asthma trajectories and phenotypes in children, and those beginning in adulthood. Therefore, deciphering underlying determinants for different childhood and adult asthma phenotypes is urgently needed to develop personalized treatment approaches targeting distinct underlying mechanisms. Thereby, secondary prevention early in the disease process can also be achieved. The decoding of such mechanisms and their translation to the individual patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for Lung Research' (DZL).
详细描述
About 25-30% of children have at least one episode of wheeze before their 3rd birthday, but considerable clinical heterogeneity exists. Many of these children become symptom-free between 3 and 8 years of age, but some go on to persistent asthma in later childhood and adulthood. Despite its high prevalence, still little is known about pathomechanisms determining the different wheeze trajectories and phenotypes in children, and those beginning in adulthood. Frequency and severity of exacerbations may play an important role in the chronification process but underlying mechanisms are equally not well understood. Therefore, deciphering the role of airway mechanics, genetic, environmental and molecular determinants for different childhood and adult asthma phenotypes for exacerbations and chronification processes is urgently needed to develop personalized treatment approaches targeting distinct underlying mechanisms. Thereby, secondary prevention early in the disease process can also be achieved.
In order to do so, a clinical cohort for childhood asthma has been set up with identical, standardized instruments (quality assurance plan: standard operating procedures (SOPs) for clinical and lab modules, shipment, biobanking and analysis as well as quality control measures via audits and site visits have been developed) across the participating 'German Center for Lung Research' (DZL) sites. Here, new-onset steroid/leukotriene receptor antagonist (LTRA) naïve wheeze/asthma patients and wheeze/asthma patients under controller therapy are being recruited in addition to healthy controls. Following recruitment, regularly follow-ups and exacerbation visits of included patients are being performed with identical study instruments and meticulous quality control checks as at baseline.
PROJECT HYPOTHESES:
- Specific molecular phenotypes are associated with distinct wheeze/asthma phenotypes and trajectories. Thereby, underlying mechanisms as well as predictors and biomarkers for persistent asthma will be identified.
- Individuals at risk for exacerbations can be identified by clinical and molecular biomarkers, which will become novel targets for therapy and secondary prevention.
WORK PROGRAM:
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 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent by parents (and by children if age > 8 years)
- •age 6 months to 18 years
- •term delivery (≥ 37 weeks)
- •active/passive understanding of German
- •age 6 months - < 6 years: preschool wheeze (more than two episodes of wheeze during 12 months prior to inclusion)
- •age at least 6 years: doctor diagnosed asthma (according to current guidelines)
排除标准
- •known inborn or perinatal pulmonary disease
- •airway malformation
- •oxygen therapy after birth with a duration of more than 24 hours
- •ventilator support or mechanical ventilation after birth
- •diagnoses of cystic fibrosis; primary ciliary dyskinesia
- •heart failure diagnosed after birth affecting pulmonary circulation
- •major respiratory diseases such as e.g. interstitial lung disease
- •any current non-atopic comorbidity
- •fever of at least 38.5°C during the last two weeks prior to the planned first visit
结局指标
主要结局
Prevalence of asthma
时间窗: At baseline and during yearly follow-ups up to 2 years
Study participants will be assessed with regard to their development of asthma.
Prevalence of transient preschool wheeze
时间窗: At baseline and during yearly follow-ups up to 2 years
Study participants will be assessed with regard to their development of transient preschool wheeze.
次要结局
- Frequency of acute exacerbations during previous 12 months(At baseline and during yearly follow-ups up to 2 years)
- Lung function(At baseline and during yearly follow-ups up to 2 years)
- Levels of exhaled nitric oxide(At baseline and during yearly follow-ups up to 2 years)
- Prevalence of atopic sensitization(At baseline and during yearly follow-ups up to 2 years)
研究者
Erika von Mutius
Prof. Dr. Bianca Schaub
LMU Klinikum