Airway Microbiota Based Treatment of Asthma in Preschool Children

Asthma in Children Clinical Trial

— AMBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527016
• Other study ID #: QYY1.0
• Status: Recruiting
• Phase: Phase 4
• Start date: October 18, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Children's Hospital of Fudan University
• Contact: Yuanyuan Qi
• Phone: 86-021-64931129
• Email: qiyuanyuan3636[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Procedure:
• Microbiota and eosinophils based therapy
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.

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: 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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	from baseline to one year follow-up
Secondary	Frequency of emergency department visit	the number of emergency visit is recorded by the physician and confirmed by the medical records	from baseline to one year follow-up
Secondary	Frequency of hospital admissions	the number of emergency visit is confirmed by the medical records	from baseline to one year follow-up
Secondary	The changes of TRACK score	assessed by questionnaire	from baseline to one year follow-up
Secondary	The changes of PACQLQ score	assessed by questionnaire	from baseline to one year follow-up