Airway Microbiota Based Treatment of Asthma in Preschool Children
- Conditions
- Asthma in Children
- Interventions
- Procedure: Microbiota and eosinophils based therapyDrug: Clinical guidelines based therapy
- Registration Number
- NCT04527016
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Microbiota and eosinophils phenotype based therapy Microbiota and eosinophils 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. Clinical guidelines based therapy 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.
- Primary Outcome Measures
Name Time Method Frequency of unscheduled healthcare visits for wheezing from baseline to one year follow-up the number of visits for wheezing is recorded by the physician
- Secondary Outcome Measures
Name Time Method Frequency of severe wheezing requiring oral or intravenous steroids from baseline to one year follow-up the number of courses of an oral prednisolone or intravenous methylprednisolone started for acute wheezing after consultation with a physician, and is recorded by the physician or confirmed by the medical records
The changes of TRACK score from baseline to one year follow-up assessed by questionnaire
Frequency of emergency department visit from baseline to one year follow-up the number of emergency visit is recorded by the physician and confirmed by the medical records
Frequency of hospital admissions from baseline to one year follow-up the number of emergency visit is confirmed by the medical records
The changes of PACQLQ score from baseline to one year follow-up assessed by questionnaire
Trial Locations
- Locations (1)
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China