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Completed

NCT Number: NCT04527016

Airway Microbiota Based Treatment of Asthma in Preschool Children

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.

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Key information

Conditions

Asthma in Children

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiota and eosinophils based therapy

Procedure
  • 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.

Clinical guidelines based therapy

Drug

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 outcomes

  1. Frequency of unscheduled healthcare visits for wheezing

    Time frame: from baseline to one year follow-up

    the number of visits for wheezing is recorded by the physician

Secondary outcomes

  1. Frequency of severe wheezing requiring oral or intravenous steroids

    Time frame: 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

  2. Frequency of emergency department visit

    Time frame: from baseline to one year follow-up

    the number of emergency visit is recorded by the physician and confirmed by the medical records

  3. Frequency of hospital admissions

    Time frame: from baseline to one year follow-up

    the number of emergency visit is confirmed by the medical records

  4. The changes of TRACK score

    Time frame: from baseline to one year follow-up

    assessed by questionnaire

  5. The changes of PACQLQ score

    Time frame: from baseline to one year follow-up

    assessed by questionnaire

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Acronym: AMBT

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 26, 2020
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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