Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiota and eosinophils based therapy | Procedure |
The participants will be followed up for one year after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064307 | Microbiota |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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:
The participants will be followed up for one year after the intervention. |
|
| 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 |
| Frequency of hospital admissions | the number of emergency visit is confirmed by the medical records | from baseline to one year follow-up |
| The changes of TRACK score | assessed by questionnaire | from baseline to one year follow-up |
| The changes of PACQLQ score | assessed by questionnaire | from baseline to one year follow-up |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |