Airway Microbiota Based Treatment of Asthma in Preschool Children

NCT04527016 | Completed Phase 4

• 1 other identifier: QYY1.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

preschool wheeze; airway microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Frequency of severe wheezing requiring oral or intravenous steroids

  from baseline to one year follow-up

• Frequency of emergency department visit

  from baseline to one year follow-up

• Frequency of hospital admissions

  from baseline to one year follow-up

• The changes of TRACK score

  from baseline to one year follow-up

• The changes of PACQLQ score

  from baseline to one year follow-up

Study Arms (2)

Microbiota and eosinophils phenotype based therapy

EXPERIMENTAL

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

Clinical guidelines based therapy

ACTIVE COMPARATOR

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

Interventions

Microbiota and eosinophils based therapy PROCEDURE

1. Blood eosinophils ≥3%+ mixed airway microbiota: 3 month course of FP 50 ug twice daily via spacer 2. Blood eosinophils\<3%+ Moraxella species\>40% in airway microbiota: Azithromycin 10mg/kg per day for 3 consecutive days a week for 4 weeks; 3. 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; 4. 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.

Microbiota and eosinophils phenotype based therapy

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: 1. regular inhaled FP 50 ug twice daily via spacer for 3 months; 2. montelukast(4mg od for 3 months) 3. 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.

Clinical guidelines based therapy

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Interventions

Microbiota

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 26, 2020
• Study Start: October 18, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 20, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)