Asthma in ChildrenPhase 4AMBTNCT04527016
Airway Microbiota Based Treatment of Asthma in Preschool Children
A Phase 4 study testing Microbiota and eosinophils based therapy and Clinical guidelines based therapy in people with Asthma in Children, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Microbiota and eosinophils based therapy and Clinical guidelines based therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 20 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
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.
Read the detailed 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.
- Conditions
- Asthma in Children
- Being tested
- Microbiota and eosinophils based therapy, Clinical guidelines based therapy
- Keywords
- preschool wheeze, airway microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota and eosinophils based therapyProcedure or surgery
- 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.
Clinical guidelines based therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Microbiota and eosinophils based therapy |
| 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. Receives: Drug: Clinical guidelines based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unscheduled healthcare visits for wheezing
the number of visits for wheezing is recorded by the physician
Measured: from baseline to one year follow-up
Secondary outcomes (5)
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
Measured: from baseline to one year follow-up
Frequency of emergency department visit
the number of emergency visit is recorded by the physician and confirmed by the medical records
Measured: from baseline to one year follow-up
Frequency of hospital admissions
the number of emergency visit is confirmed by the medical records
Measured: from baseline to one year follow-up
The changes of TRACK score
assessed by questionnaire
Measured: from baseline to one year follow-up
The changes of PACQLQ score
assessed by questionnaire
Measured: from baseline to one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start18 Oct 2021
- Primary completion15 Jun 2023
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527016
- Sponsor's protocol ID
- QYY1.0
- Acronym
- AMBT
- Status last verified
- Jul 2024
- First submitted
- 22 Aug 2020
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Airway Microbiota and Blood Eosinophils Based Therapy or Treatment Using Current Clinical Guidelines in Recurrent Preschool Wheeze
- ClinicalTrials.gov ID
- NCT04527016
- Acronym / sponsor ID
- AMBT / QYY1.0
- Conditions
- Asthma in Children
- Keywords
- preschool wheeze, airway microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbiota and eosinophils phenotype based therapy | Experimental | Procedure: Microbiota and eosinophils based therapyThe 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 | Drug: Clinical guidelines based therapyThe 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota and eosinophils based therapy1. 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. | Procedure or surgery | Microbiota and eosinophils phenotype based therapy |
| Clinical guidelines based therapyThe 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. | Drug | Clinical guidelines based therapy |
Primary outcome
Frequency of unscheduled healthcare visits for wheezing
Time frame: from baseline to one year follow-up
the number of visits for wheezing is recorded by the physician
5 secondary outcomes
Frequency of severe wheezing requiring oral or intravenous steroids
Time frame: from baseline to one year follow-up
Frequency of emergency department visit
Time frame: from baseline to one year follow-up
Frequency of hospital admissions
Time frame: from baseline to one year follow-up
The changes of TRACK score
Time frame: from baseline to one year follow-up
The changes of PACQLQ score
Time frame: from baseline to one year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microbiota and eosinophils based therapy and Clinical guidelines based therapy in people with Asthma in Children, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of unscheduled healthcare visits for wheezing (time frame: from baseline to one year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.