Airway Microbiota Based Treatment of Asthma in Preschool Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze

Conditions
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Asthma in Children

Intervention / Treatment
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* Procedure: Microbiota and eosinophils based therapy
* Drug: Clinical guidelines based therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months） Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microbiota and eosinophils phenotype based therapy<br>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. | Procedure: Microbiota and eosinophils based therapy<br>* Blood eosinophils ≥3%+ mixed airway microbiota: 3 month course of FP 50 ug twice daily via spacer Blood eosinophils<3%+ Moraxella species>40% in airway microbiota: Azithromycin 10mg/kg per day for 3 consecutive days a week for 4 weeks; Blood eosinophils ≥3%+ Moraxella species>40% in airway microbiota: 3 month course of FP 50 ug twice daily via spacer and Azithromycin 10mg/kg per day for 3 consecutive days a week for 4 weeks; Blood eosinophils<3%+ mixed airway microbiota: intermittent budesonide inhalation suspension (1mg twice daily) and terbutaline inhalation suspension for 7 days during wheeze episode. The participants will be followed up for one year after the intervention.<br>|
| Active Comparator: Clinical guidelines based therapy<br>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. | Drug: Clinical guidelines based therapy<br>* 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).The treatment protocols include: regular inhaled FP 50 ug twice daily via spacer for 3 months; montelukast(4mg od for 3 months) intermittent budesonide inhalation suspension (1mg twice daily for 7 days during wheeze episode). The participants will be followed up for one year after the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of unscheduled healthcare visits for wheezing | the number of visits for wheezing is recorded by the physician | from baseline to one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of severe wheezing requiring oral or intravenous steroids | 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 | from baseline to one year follow-up | 
| Frequency of emergency department visit | the number of emergency visit is recorded by the physician and confirmed by the medical records | from baseline to one year follow-up | 
| Frequency of hospital admissions | the number of emergency visit is confirmed by the medical records | from baseline to one year follow-up | 
| The changes of TRACK score | assessed by questionnaire | from baseline to one year follow-up | 
| The changes of PACQLQ score | assessed by questionnaire | from baseline to one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preschool wheeze, airway microbiota