Airway Microbiota Based Treatment of Asthma in Preschool Children

PHASE4CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 18, 2021

Primary Completion Date

June 15, 2023

Study Completion Date

June 20, 2024

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."

Trial Locations (1)

201102

Children's Hospital of Fudan University, Shanghai

All Listed Sponsors
lead

Children's Hospital of Fudan University

OTHER

NCT04527016 - Airway Microbiota Based Treatment of Asthma in Preschool Children | Biotech Hunter | Biotech Hunter