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Airway Microbiota Based Treatment of Asthma in Preschool Children

NCT04527016 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-10

No results posted yet for this study

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

Interventions

PROCEDURE

Microbiota and eosinophils based therapy

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.

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: 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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2023-06-15
Completion
2024-06-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527016 on ClinicalTrials.gov