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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Procedure: Microbiota and eosinophils based therapy; Drug: Clinical guidelines based therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Microbiota and eosinophils based therapy; 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.
Active Comparator: 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.	Drug: 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).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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: preschool wheeze; airway microbiota
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: QYY1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No