Clinical trial
Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
Name
QYY1.0
Description
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.
Trial arms
Trial start
2021-10-18
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Microbiota and eosinophils phenotype based therapy
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.
Arms:
Clinical guidelines based therapy
Size
140
Primary endpoint
Frequency of unscheduled healthcare visits for wheezing
from baseline to one year follow-up
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}
Updated at
2023-03-14
1 organization
1 product
1 indication
Organization
Children's Hospital of Fudan UniversityIndication
Asthma in Children