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

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Microbiota and eosinophils based therapy
Clinical guidelines based therapy
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring preschool wheeze, airway microbiota

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microbiota and eosinophils phenotype based therapy

Clinical guidelines based therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Frequency of unscheduled healthcare visits for wheezing
the number of visits for wheezing is recorded by the physician

Secondary Outcome Measures

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
Frequency of emergency department visit
the number of emergency visit is recorded by the physician and confirmed by the medical records
Frequency of hospital admissions
the number of emergency visit is confirmed by the medical records
The changes of TRACK score
assessed by questionnaire
The changes of PACQLQ score
assessed by questionnaire

Full Information

First Posted
August 22, 2020
Last Updated
March 12, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04527016
Brief Title
Airway Microbiota Based Treatment of Asthma in Preschool Children
Acronym
AMBT
Official Title
Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
preschool wheeze, airway microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microbiota and eosinophils phenotype based therapy
Arm Type
Experimental
Arm 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.
Arm Title
Clinical guidelines based therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Microbiota and eosinophils based therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Clinical guidelines based therapy
Intervention 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).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.
Primary Outcome Measure Information:
Title
Frequency of unscheduled healthcare visits for wheezing
Description
the number of visits for wheezing is recorded by the physician
Time Frame
from baseline to one year follow-up
Secondary Outcome Measure Information:
Title
Frequency of severe wheezing requiring oral or intravenous steroids
Description
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
Time Frame
from baseline to one year follow-up
Title
Frequency of emergency department visit
Description
the number of emergency visit is recorded by the physician and confirmed by the medical records
Time Frame
from baseline to one year follow-up
Title
Frequency of hospital admissions
Description
the number of emergency visit is confirmed by the medical records
Time Frame
from baseline to one year follow-up
Title
The changes of TRACK score
Description
assessed by questionnaire
Time Frame
from baseline to one year follow-up
Title
The changes of PACQLQ score
Description
assessed by questionnaire
Time Frame
from baseline to one year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Qi
Phone
86-021-64931129
Email
qiyuanyuan3636@hotmail.com
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Qi
Email
qiyuanyuan3636@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Airway Microbiota Based Treatment of Asthma in Preschool Children

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