NL-OMON36534招募中不适用
nbiased BIOmarkers for the Prediction of REspiratory Disease outcomes: understanding severe asthma in children - UBIOPRED: understanding severe asthma in children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Severe school aged asthma cohort: 6-17yrs old, persistent asthma symptoms or frequent severe exacerbations or persistent airflow limitation despite the prescription of high dose ICS or prescription of maintenance OCS
- •Mild-moderate school aged asthma cohort: 6-17yrs old, controlled asthma symptoms (according to GINA guidelines) with the prescription of low to moderate dose ICS
- •Severe pre school wheeze cohort: 1-5yrs old, persistent symptoms or frequent severe exacerbations despite the prescription of high dose ICS (or failed trial) or prescription of maintenance OCS
- •Mild-moderate pre school wheeze cohort: 1-5yrs old, controlled symptoms (according to GINA guidelines) with the prescription of low to moderate dose ICS (or failed trial).
- •See protocol page 35 to 40 for protocol specific inclusion criteria.
排除标准
- •1. As a result of medical interview, physical examination or screening investigation the responsible physician considers the child unfit for the study.
- •2. The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
- •3. 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
- •4. 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.
- •5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
- •6. Prematurity *37 weeks gestation
- •7. The child had changed medication within 4 weeks of the screening assessment (assessment should be deferred)
- •8. 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).
- •9. 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).
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