Protocol for the European Multi-Centre Study Understanding Severe Asthma Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Asthma exacerbations
研究概览
简要总结
Cross-sectional study to characterize cohorts of children with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for children with severe asthma
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
- •Assent should be obtained from all children in the study where appropriate.
- •Male or female subject aged between 1 - 17 years inclusive at screening.
- •The parent / guardian, or where appropriate the child must be able to read, comprehend, and write at a sufficient level to complete study related materials.
- •Subjects will be allowed to enrol in other studies while taking part on this study. However, Permission from the Scientific Board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.
排除标准
- •As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
- •The subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
- •Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
- •The child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
- •Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
- •Prematurity ≤35 weeks gestation
- •The child had changed asthma medication within 4 weeks of the screening assessment(except those using the Symbicort maintenance and reliever therapy (SMART) regime)(assessment should be deferred)
- •History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
- •The child has had a severe exacerbation (requiring ER attendance or hospital admission and/or a course of high dose OCS for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
结局指标
主要结局
Asthma exacerbations
时间窗: 3 years
Lung function decline over the course of the study
时间窗: 3 years
Changes in asthma medication
时间窗: 3 years
Daily symptoms and short acting beta agonist (SABA) usage
时间窗: 3 years
Asthma control questionnaire (ACQ) at baseline and changes over the course of the study
时间窗: 3 years
Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study
时间窗: 3 years
Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study
时间窗: 3 years
Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique
时间窗: 3 years
Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure
时间窗: 3 years
Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)
时间窗: 3 years
Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)
时间窗: 3 years
Histopathology of bronchial biopsies in a sub group of subjects
时间窗: 3 years
Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies
时间窗: 3 years
Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)
时间窗: 3 years
次要结局
未报告次要终点
研究者
Prof. dr. P.J. Sterk
Prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)