Airway Microbiota Based Treatment of Asthma in Preschool Children (AMBT)

Fudan University

Status and phase: Completed; Phase 4

Conditions: Asthma in Children

Treatments: Procedure: Microbiota and eosinophils based therapy; Drug: Clinical guidelines based therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04527016

QYY1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Microbiota and eosinophils phenotype based therapy

Experimental group

Description:

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.

Treatment:

Procedure: Microbiota and eosinophils based therapy

Clinical guidelines based therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Clinical guidelines based therapy