Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Frequency of unscheduled healthcare visits for wheezing
研究概览
简要总结
Airway microbiota pattern may related the preschool asthma exacerbation. This is a single-center, randomized-controlled trial, the study will compare the management of preschool wheeze determined by airway microbiota phenotype and blood eosinophils level to the management using current clinical guidelines.
详细描述
In this study, participants will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of two treatment groups, either current clinical care or airway microbiota and blood eosinophils phenotype based management for 3 months.They will be followed up for one year after the intervention. The primary outcome is the frequency of unscheduled healthcare visit for wheezing, the secondary outcome parameters are events of severe wheezing requiring oral or intravenous steroids, events of emergency department visit and hospital admissions, the changes of Test for Respiratory and Asthma Control in Kids (TRACK) score and Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）
排除标准
- •Any congenital heart disease diagnosed by a physician
- •Any chronic respiratory condition other than preschool wheeze (bronchopulmonary dysplasia, bronchiolitis obliteran, congenital airway and lung malformations, bronchomalacia, chronic aspiration) diagnosed by a physician
- •Received antibiotic last 6 weeks
研究组 & 干预措施
Microbiota and eosinophils phenotype based therapy
The children will be treated with different protocol(Fluticasone propionate (FP),Azithromycin,or FP+Azithromycin) according to their Blood eosinophils level and airway microbiota pattern for 3 months and follow up for 1 year.
干预措施: Microbiota and eosinophils based therapy (Procedure)
Clinical guidelines based therapy
The children will be treated as directed by their paediatrician, the clinical practice is based on the guideline for the diagnosis and optimal management of asthma in children of China 2016 (FP or montelukast for 3 months，or intermittent budesonide inhalation suspension during wheezing episode) and follow up for 1 year.
干预措施: Clinical guidelines based therapy (Drug)
结局指标
主要结局
Frequency of unscheduled healthcare visits for wheezing
时间窗: from baseline to one year follow-up
the number of visits for wheezing is recorded by the physician
次要结局
- Frequency of severe wheezing requiring oral or intravenous steroids(from baseline to one year follow-up)
- The changes of TRACK score(from baseline to one year follow-up)
- Frequency of emergency department visit(from baseline to one year follow-up)
- Frequency of hospital admissions(from baseline to one year follow-up)
- The changes of PACQLQ score(from baseline to one year follow-up)