Development of Non-invasive Biomarkers to Direct Individualised Management of Preschool Wheeze
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Longitudinal study of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection
研究概览
简要总结
Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations. This has not changed over 20 years, meaning current treatments are not working and a new approach is needed. Currently, all preschool wheezers are treated with inhaled steroids. However, only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. This research group has found that some preschool wheezers may have other causes but there are no specific, non-invasive tests to match the right treatment to each child.
The goal of this observational study is to test various bedside tests for this purpose in preschool children with wheeze, to see if they are feasible, accurate and acceptable in this age group.
The research team would like to investigate the following aims:
Aim 1 - To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation.
Aim 2 - To test the acceptability of these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use.
Aim 3- A small proof-of -concept study, to test if these simple bedside tests, can be used to determine treatment for each individual child.
The panel of simple non-invasive tests that the research team are proposing are:
- Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds)
- Finger prick blood test
- Phlegm test for bacteria
- Nose and throat swab for bacteria
- Lung function test called forced oscillation technique (FOT)
详细描述
Research Question:
Can the research team identify simple bedside tests that can give quick, accurate results while being acceptable to parents and children, and can these tests be successfully used in clinical practice, to decide treatment for preschool wheeze?
Participants will be asked to do these simple tests- skin prick test, finger prick blood test, breathing test, throat swab, and a test to catch their phlegm. The researchers will use two tests to identify children who are likely to respond to inhaled steroids: skin tests for allergies and a finger prick blood test. To identify children with bacterial infections in their lungs, where antibiotics will be useful, the team will obtain a sample of sputum (phlegm) after a salty mist inhalation (saline nebuliser), and will test the accuracy of a throat swab that detects bacteria. The research team will also test how cells called neutrophils work in children without allergies or infection with the same finger prick blood test above. A breathing test called forced oscillation will be used to identify children who may respond to their reliever "blue" inhaler during wheezing attacks.
The research team will also recruit a small number of children, for a trial in which their treatment will be guided by their test result, to see if parents are willing to take part in such a study, before designing a larger trial. This study will be the first to show that new tests can identify different types of preschool wheezing and can be used to plan treatment based on individual children's needs. Researchers will compare to see if children who have their treatment based on the simple bedside tests do better than the children who are just given inhaled steroids.
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
- •Aim 1, 2 and 3:
- •Children aged 1-5 years
- •More than 2 hospitalisations for acute wheeze in the last year or
- •At least 1 admission requiring high dependency unit or intravenous bronchodilator therapy in the last year.
- •Aim 1 only:
- •children undergoing clinically indicated bronchoscopy, as determined by their existing medical team, as part of their standard management
排除标准
- •Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis.
结局指标
主要结局
Longitudinal study of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection
时间窗: 3 years
Specificity, sensitivity and longitudinal stability of oropharyngeal swab and induced sputum PCR (measured by detectable presence or absence of DNA from Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis) as biomarkers of airway infection. Concordance between oropharyngeal swab and induced sputum PCR results from the same patient will also be assessed.
Longitudinal study of skin prick tests as biomarkers of preschool wheeze
时间窗: 3 years
Specificity, sensitivity and longitudinal stability of skin prick tests to six common allergens (measured by size of wheal in response to skin prick, measured in mm) as a biomarker of allergen sensitisation.
Longitudinal study of finger-prick point of care test for eosinophil count as a biomarker of preschool wheeze
时间窗: 3 years
Specificity, sensitivity and longitudinal stability of a finger-prick point of care test for eosinophil count (measured as cells per cubic mm) as a biomarker of eosinophilic inflammation.
Longitudinal study of blood neutrophil phenotype as a biomarker of airway infection
时间窗: 3 years
Specificity, sensitivity and longitudinal stability of blood neutrophil phenotype (measured as mean fluorescence intensity for indicative phenotype markers) as a biomarker of airway infection.
Longitudinal study of blood neutrophil chemotaxis as a biomarker of wheezing phenotype
时间窗: 3 years
Specificity, sensitivity and longitudinal stability of blood neutrophil chemotaxis (measured in micrometers per minute) as a biomarker of wheezing phenotype.
Longitudinal study of lung function test (FOT) as a biomarker of airway reversibility
时间窗: 3 years
Specificity, sensitivity and longitudinal stability of lung function test (forced oscillation technique or FOT), measured by lung reactance and lung resistance (Rrs: respiratory system resistance; Xrs: respiratory system reactance; AX: area of reactance), as biomarkers of airway reversibility in wheezing patients.
次要结局
- Patient acceptability of finger prick blood eosinophil count as a non-invasive biomarker in preschool wheeze(3 years)
- Patient acceptability of forced oscillation technique as a non-invasive biomarker to determine lung function and airway reversibility in preschool wheeze(3 years)
- Patient acceptability of skin prick test as a non-invasive biomarker in preschool wheeze(3 years)
- Association between eosinophil counts and patient symptom control(3 years)
- Patient acceptability of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection in preschool wheeze(3 years)
- Correlation between eosinophil counts and symptom burden of preschool wheeze to caregivers(3 years)