Asthma in ChildrenNCT06796387
SMART-School-based Asthma Therapy
A study testing SMART-SBAT in people with Asthma in Children, run by University of Rochester.
Trial summary
The goal of this research trial is to: 1) Develop a SMART-SBAT protocol specifically designed for schools, 2) Evaluate the effectiveness of SMART-SBAT vs. usual care using a district wide, stepped-wedge type 1 cluster randomized trial and 3) Evaluate the process of implementing SMART-SBAT to contextualize… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- SMART-SBAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician-diagnosed asthma, with moderate-severe persistent symptoms or poor control based on NHLBI criteria
- Age >=6 and =<12 years
- Attending school in Rochester City School District
- Caregiver >=18 years, and is able to understand and speak English or Spanish
Who cannot join
- Caregiver inability to speak and understand English or Spanish. (*Participants unable to read will be eligible, and all instruments will be given verbally.)
- Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- In foster care or other situations in which consent cannot be obtained from a guardian.
- Based on prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SMART-SBAT: Transforming Pediatric Asthma Care Through School-Based Single-Inhaler Therapy
The goal of this research trial is to: 1) Develop a SMART-SBAT protocol specifically designed for schools, 2) Evaluate the effectiveness of SMART-SBAT vs. usual care using a district wide, stepped-wedge type 1 cluster randomized trial and 3) Evaluate the process of implementing SMART-SBAT to contextualize effectiveness outcomes and inform future scale-up.
Read the detailed description
Despite well-established asthma guidelines and effective preventive medications, many children with persistent asthma do not receive recommended daily anti-inflammatory therapy, and follow-up care with guideline-based step-up adjustments and specialty evaluation is inconsistent. Over a decade ago, in partnership with the Rochester City School District, the investigators co-developed the School-Based Asthma Therapy (SBAT) program to enhance adherence to guideline-based treatment through school-based directly observed therapy (DOT) of preventive medications. Research demonstrated reductions in exacerbations and asthma symptoms, and key stakeholders strongly supported program continuation and scale-up. However, despite its clinical impact, SBAT has not been broadly implemented or sustained outside research trials, and some children continued to have suboptimal asthma control. Recent guideline endorsement of single maintenance and reliever therapy (SMART) offers a timely opportunity to accelerate translation of evidence-based asthma care into real-world practice. SMART simplifies asthma management, improves symptom control, and enables rapid intensification of anti-inflammatory therapy when control remains poor, yet uptake in routine pediatric care remains limited. To address this critical implementation gap and advance pediatric asthma care, the investigators plan to initiate SMART-SBAT, integrating a single ICS-formoterol inhaler at school for both DOT and symptom-driven use. Because school nurses already manage reliever medications, replacing separate controller and reliever inhalers with a single ICS-formoterol inhaler simplifies medication management, facilitates rapid adoption of SMART within existing school health workflows, and enables a "natural" step-up in therapy when symptoms occur. By embedding guideline-recommended SMART delivery in schools, SMART-SBAT provides a pragmatic pathway to accelerate real-world implementation at scale. SMART-SBAT also provides a platform to evaluate treatment response under conditions of reliable medication exposure, including differential effects by asthma phenotype and environmental context, while facilitating specialty evaluation for children with ongoing poor control. Using a pragmatic Type 1 hybrid stepped-wedge trial, the investigators will evaluate effectiveness while simultaneously assessing implementation processes relevant to real-world delivery. Approximately 330 caregivers in SMART-SBAT and usual care schools will be enrolled for longitudinal surveys and medical record reviews to assess outcomes (primary outcome = urgent care and emergency visits for asthma over 12 months). Explanatory mixed-methods analyses will assess reach, fidelity, dose, and adaptations, and evaluate whether baseline clinical characteristics, environmental exposures, and social context modify response to SMART-SBAT. Findings will inform foundational components of a SMART-SBAT toolkit to support broader dissemination. By accelerating uptake of simplified, guideline-based therapy within routine school systems and enabling evaluation beyond adherence barriers, SMART-SBAT aims to reduce exacerbations, improve asthma control, and generate actionable evidence for scalable, high-quality asthma care.
- Conditions
- Asthma in Children
- Being tested
- SMART-SBAT, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART-SBATBehavioural
In coordination and approval by the child's primary care or specialist provider, children will receive a single maintenance and reliever therapy (SMART) inhaler for school-based asthma therapy (SBAT). Supervised by the school nurse, children will use their prescribed SMART inhaler each school day for preventive therapy, with additional doses as needed to relieve symptoms. Follow-up control assessments will determine if a step-up in therapy may be warranted, and follow-up provider visits will be initiated through school-based telemedicine or in-person visits. An Asthma Coordination team (nurse and community health worker) will be available to coordinate asthma care between providers, pharmacies, schools and families, and provide additional pragmatic support as needed.
Usual CareBehavioural
Children enrolled in usual care schools will continue to receive asthma management through existing healthcare providers, schools will provide reliever inhalers as prescribed, and preventive asthma therapy is prescribed and delivered through normal channels. Each school year, all school nurses will receive a general orientation on guideline-based asthma management, including SMART and potential benefits of school-based asthma therapy, but standardized workflows or structured coordination will not be available for usual care schools. Caregivers and primary care providers will receive notifications of the child's asthma symptoms and recommendations for SMART therapy.
| Study group | Role | What they receive |
|---|---|---|
| SMART-SBAT | Experimental | In coordination and approval by the child's primary care or specialist provider, children will receive a single maintenance and reliever therapy (SMART) inhaler for school-based asthma therapy (SBAT). Supervised by the school nurse, children will use their prescribed SMART inhaler each school day for preventive therapy, with additional doses as needed to relieve symptoms. Follow-up control assessments will determine if a step-up in therapy may be warranted, and follow-up provider visits will be initiated through school-based telemedicine or in-person visits. An Asthma Coordination team (nurse and community health worker) will be available to coordinate asthma care between providers, pharmacies, schools and families, and provide additional pragmatic support as needed. Receives: Behavioral: SMART-SBAT |
| Usual Care (UC) | Active comparator | Children enrolled in usual care schools will continue to receive asthma management through existing healthcare providers, schools will provide reliever inhalers as prescribed, and preventive asthma therapy is prescribed and delivered through normal channels. Each school year, all school nurses will receive a general orientation on guideline-based asthma management, including SMART and potential benefits of school-based asthma therapy, but standardized workflows or structured coordination will not be available for usual care schools. Caregivers and primary care providers will receive notifications of the child's asthma symptoms and recommendations for SMART therapy. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children with one or more acute health care visits due to asthma over 12 months
The percentage of children who experience one or more acute health care visits (emergency, urgent care) for asthma over 12 months
Measured: 12 months
Secondary outcomes (14)
Mean number of symptom-free days in prior 14 days
Mean number of symptom-free days (24 hours without symptoms) in prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).
Measured: 12-month follow-ups
Mean number of nights with asthma symptoms in prior 2 weeks
Mean number of nights with asthma symptoms in the prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).
Measured: 12 months
Mean number of days requiring use of reliever medication in prior 14 days
Mean number of days requiring reliever therapy in the prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).
Measured: 12 months
Quality of Life Score at 12 months
Pediatric Asthma Caregiver Quality of Life score at each follow-up. Scores range from1-7, higher scores indicate better quality of life.
Measured: 12 months
Asthma Control Score at 12 months
Asthma control score as indicated by the Pediatric Asthma Impairment and Risk Questionnaire (Peds-AIRQ); scores range 0-8; lower scores indicate better asthma control
Measured: 12 months
Number of oral corticosteroid bursts and hospitalizations due to asthma symptoms over 12 months
Total number of oral corticosteroid bursts and hospitalizations over 12 months
Measured: 12 months
FEV1 level
Lung function measured by most recent FEV1 level listed in medical record
Measured: 12 months
Absenteeism due to asthma
Number of days participant misses school due to asthma
Measured: 12 months
Medication Adherence
Caregiver report of missed doses, school medication administration records, Horne Adherence Scale
Measured: 12 months
Program Reach
Proportion of eligible students that enroll into SMART-SBAT
Measured: 12 months
Program Fidelity
Proportion of children where all SMART-SBAT components are delivered (screening, assessment, initiation of SMART-based therapy, and administration of medications in school)
Measured: 12 months
Program Dose
Mean number of program contacts completed per child
Measured: 12 months
Program Adoption
Proportion of schools reporting readiness and intent to adopt SMART-SBAT with the availability of a standardized toolkit
Measured: 12 Months
Program Cost Effectiveness
Evaluation of cost of program per student/participant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startDec 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionDec 2031 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, Jill Halterman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796387
- Sponsor's protocol ID
- STUDY00009394
- Status last verified
- Jan 2026
- First submitted
- 22 May 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All raw data produced in the course of the project will be preserved. All de-identified quantitative analysis datasets will be shared once the main study results have been accepted for publication. The research data from this project will be deposited within the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR) to ensure that the research community has long-term access to the data, once the main study manuscript has been accepted for publication (or by the end of the grant period; whichever comes first).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-SBAT: Transforming Pediatric Asthma Care Through School-Based Single-Inhaler Therapy
- ClinicalTrials.gov ID
- NCT06796387
- Acronym / sponsor ID
- STUDY00009394
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 28 Jan 2025 (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.
The goal of this research trial is to: 1) Develop a SMART-SBAT protocol specifically designed for schools, 2) Evaluate the effectiveness of SMART-SBAT vs. usual care using a district wide, stepped-wedge type 1 cluster randomized trial and 3) Evaluate the process of implementing SMART-SBAT to contextualize effectiveness outcomes and inform future scale-up.
Detailed description
Despite well-established asthma guidelines and effective preventive medications, many children with persistent asthma do not receive recommended daily anti-inflammatory therapy, and follow-up care with guideline-based step-up adjustments and specialty evaluation is inconsistent. Over a decade ago, in partnership with the Rochester City School District, the investigators co-developed the School-Based Asthma Therapy (SBAT) program to enhance adherence to guideline-based treatment through school-based directly observed therapy (DOT) of preventive medications. Research demonstrated reductions in exacerbations and asthma symptoms, and key stakeholders strongly supported program continuation and scale-up. However, despite its clinical impact, SBAT has not been broadly implemented or sustained outside research trials, and some children continued to have suboptimal asthma control. Recent guideline endorsement of single maintenance and reliever therapy (SMART) offers a timely opportunity to accelerate translation of evidence-based asthma care into real-world practice. SMART simplifies asthma management, improves symptom control, and enables rapid intensification of anti-inflammatory therapy when control remains poor, yet uptake in routine pediatric care remains limited. To address this critical implementation gap and advance pediatric asthma care, the investigators plan to initiate SMART-SBAT, integrating a single ICS-formoterol inhaler at school for both DOT and symptom-driven use. Because school nurses already manage reliever medications, replacing separate controller and reliever inhalers with a single ICS-formoterol inhaler simplifies medication management, facilitates rapid adoption of SMART within existing school health workflows, and enables a "natural" step-up in therapy when symptoms occur. By embedding guideline-recommended SMART delivery in schools, SMART-SBAT provides a pragmatic pathway to accelerate real-world implementation at scale. SMART-SBAT also provides a platform to evaluate treatment response under conditions of reliable medication exposure, including differential effects by asthma phenotype and environmental context, while facilitating specialty evaluation for children with ongoing poor control. Using a pragmatic Type 1 hybrid stepped-wedge trial, the investigators will evaluate effectiveness while simultaneously assessing implementation processes relevant to real-world delivery. Approximately 330 caregivers in SMART-SBAT and usual care schools will be enrolled for longitudinal surveys and medical record reviews to assess outcomes (primary outcome = urgent care and emergency visits for asthma over 12 months). Explanatory mixed-methods analyses will assess reach, fidelity, dose, and adaptations, and evaluate whether baseline clinical characteristics, environmental exposures, and social context modify response to SMART-SBAT. Findings will inform foundational components of a SMART-SBAT toolkit to support broader dissemination. By accelerating uptake of simplified, guideline-based therapy within routine school systems and enabling evaluation beyond adherence barriers, SMART-SBAT aims to reduce exacerbations, improve asthma control, and generate actionable evidence for scalable, high-quality asthma care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART-SBAT | Experimental | Behavioral: SMART-SBATIn coordination and approval by the child's primary care or specialist provider, children will receive a single maintenance and reliever therapy (SMART) inhaler for school-based asthma therapy (SBAT). Supervised by the school nurse, children will use their prescribed SMART inhaler each school day for preventive therapy, with additional doses as needed to relieve symptoms. Follow-up control assessments will determine if a step-up in therapy may be warranted, and follow-up provider visits will be initiated through school-based telemedicine or in-person visits. An Asthma Coordination team (nurse and community health worker) will be available to coordinate asthma care between providers, pharmacies, schools and families, and provide additional pragmatic support as needed. |
| Usual Care (UC) | Active comparator | Behavioral: Usual CareChildren enrolled in usual care schools will continue to receive asthma management through existing healthcare providers, schools will provide reliever inhalers as prescribed, and preventive asthma therapy is prescribed and delivered through normal channels. Each school year, all school nurses will receive a general orientation on guideline-based asthma management, including SMART and potential benefits of school-based asthma therapy, but standardized workflows or structured coordination will not be available for usual care schools. Caregivers and primary care providers will receive notifications of the child's asthma symptoms and recommendations for SMART therapy. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Physician-diagnosed asthma, with moderate-severe persistent symptoms or poor control based on NHLBI criteria
- Age >=6 and =<12 years
- Attending school in Rochester City School District
- Caregiver >=18 years, and is able to understand and speak English or Spanish
Key exclusion criteria (4 listed)
- Caregiver inability to speak and understand English or Spanish. (*Participants unable to read will be eligible, and all instruments will be given verbally.)
- Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- In foster care or other situations in which consent cannot be obtained from a guardian.
- Based on prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.
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 |
|---|---|---|
| SMART-SBATIn coordination and approval by the child's primary care or specialist provider, children will receive a single maintenance and reliever therapy (SMART) inhaler for school-based asthma therapy (SBAT). Supervised by the school nurse, children will use their prescribed SMART inhaler each school day for preventive therapy, with additional doses as needed to relieve symptoms. Follow-up control assessments will determine if a step-up in therapy may be warranted, and follow-up provider visits will be initiated through school-based telemedicine or in-person visits. An Asthma Coordination team (nurse and community health worker) will be available to coordinate asthma care between providers, pharmacies, schools and families, and provide additional pragmatic support as needed. | Behavioural | SMART-SBAT |
| Usual CareChildren enrolled in usual care schools will continue to receive asthma management through existing healthcare providers, schools will provide reliever inhalers as prescribed, and preventive asthma therapy is prescribed and delivered through normal channels. Each school year, all school nurses will receive a general orientation on guideline-based asthma management, including SMART and potential benefits of school-based asthma therapy, but standardized workflows or structured coordination will not be available for usual care schools. Caregivers and primary care providers will receive notifications of the child's asthma symptoms and recommendations for SMART therapy. | Behavioural | Usual Care (UC) |
Primary outcome
Percentage of children with one or more acute health care visits due to asthma over 12 months
Time frame: 12 months
The percentage of children who experience one or more acute health care visits (emergency, urgent care) for asthma over 12 months
14 secondary outcomes
Mean number of symptom-free days in prior 14 days
Time frame: 12-month follow-ups
Mean number of nights with asthma symptoms in prior 2 weeks
Time frame: 12 months
Mean number of days requiring use of reliever medication in prior 14 days
Time frame: 12 months
Quality of Life Score at 12 months
Time frame: 12 months
Asthma Control Score at 12 months
Time frame: 12 months
Number of oral corticosteroid bursts and hospitalizations due to asthma symptoms over 12 months
Time frame: 12 months
FEV1 level
Time frame: 12 months
Absenteeism due to asthma
Time frame: 12 months
Medication Adherence
Time frame: 12 months
Program Reach
Time frame: 12 months
Program Fidelity
Time frame: 12 months
Program Dose
Time frame: 12 months
Program Adoption
Time frame: 12 Months
Program Cost Effectiveness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. All raw data produced in the course of the project will be preserved. All de-identified quantitative analysis datasets will be shared once the main study results have been accepted for publication. The research data from this project will be deposited within the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR) to ensure that the research community has long-term access to the data, once the main study manuscript has been accepted for publication (or by the end of the grant period; whichever comes first).
Related trials for Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Active, not recruiting
Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Asthma in Children, Chronic Diseases in Children
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.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-SBAT in people with Asthma in Children, run by University of Rochester.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill S Halterman, MD, MPH (5852755798, jill_halterman@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children with one or more acute health care visits due to asthma over 12 months (time frame: 12 months). 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 29 Jan 2026.