AsthmaPhase 4EDSAMSNCT03952286
ED-Initiated School-based Asthma Medication Supervision
A Phase 4 study testing ED-Dispensing home and school supervision in people with Asthma and Asthma in Children, run by University of Arizona at 1 site in United States.
Trial summary
Asthma is a common chronic condition that causes substantial morbidity among children and much of it is attributable to medication non-adherence. The National Asthma Education and Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have urged others to develop more effective… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- ED-Dispensing home and school supervision
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Children 6-12 years of age; AND
- Treated for an asthma exacerbation as determined clinically by the principal ED provider based on symptoms such as shortness-of-breath, cough, and wheezing; AND
- Symptoms must improve following more than 1 dose of albuterol and more than 1 dose of systemic corticosteroids such that he/she can be safely discharged home; AND
- Must have physician-diagnosed
Who cannot join
- Attends a non-participating school; OR
- Attends a participating school less than 5x/week; OR
- Enrolled in another research study; OR
- Patients who are hospitalized; OR
- The patient or their consenting parent/guardian does not speak English or Spanish; OR
- ICU admissions for asthma in the past year; OR
Show all 11Show fewer
- History of more than 2 hospitalizations for asthma in past year; OR
- History of more than 2 controller medications for asthma in the past 30 days; OR
- Study medication represents a step-down in asthma therapy in the judgement of the ED physician; OR
- Parent does not have a cell phone; OR
- Parent cannot send and receive text messages.
Trial locations and contacts
1 site in 1 country.
United States1 site
Asthma & Airway Disease Research Center
Tucson, Arizona, 85724
About this study
Asthma is a common chronic condition that causes substantial morbidity among children and much of it is attributable to medication non-adherence. The National Asthma Education and Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have urged others to develop more effective adherence programs.Schools are a logical setting to deploy such interventions because they are where children congregate, spend much of their day, and are frequently monitored. Because many schools serve a high proportion of minority and low-income students, engaging them presents a unique opportunity to reach populations who experience the greatest burden of preventable morbidity.
Supervising inhaled corticosteroid (ICS) use in the school setting can increase medication adherence and reduce episodes of poor asthma control. Under certain conditions, it can also be cost-effective. However, recruiting children from school settings tends to enroll children with mild asthma and infrequent health care use. Therefore, initiating supervised treatment in these children tends to burden school personnel with unnecessary work and diminishes the program's cost-effectiveness. To address this inefficiency, the investigators propose to recruit children who are discharged from the Hospital Emergency Departments (EDs) following successful treatment of an asthma attack. Such children have much higher risk of a future asthma attack than their peers.
Read more
The Pediatric Emergency Care Applied Research Network (PECARN) com- prises10 hospital-affiliated EDs that serve 1 million acutely ill and injured children annually. Their primary research mission is to reduce childhood morbidity and mortality by establishing creative partnerships between emergency medical service providers and their surrounding communities. The networks size and geographic diversity make it uniquely situated to develop, implement, and evaluate the feasibility and effectiveness of ED-Initiated School-Based Asthma Medication Supervision (ED-SAMS).
Approximately one-third of children treated for an asthma attack within PECARN experience a second ED-managed attack within 6 months. While the NAEPP guidelines recommend that long-term ICS treatment should be initiated at ED discharge, <20% of children actually receive a prescription for controller therapy. Observational data indicate that patients who use ICS following discharge are almost half as likely as non-users to experience a repeat ED visit. Many have also argued that ED-initiated treatment could be cost-effective. However, simply providing patients with a prescription does not ensure that they will actually use it once discharged. To ensure better medication adherence, the investigators propose to dispense ICS at discharge and supervise its use in the school setting.
Read the detailed description
Approximately 8% of children in the United States have asthma. Each year, these children experience 4 million asthma attacks that result in 725,000 ED visits and 100,000 hospitalizations. Unsurprisingly, the direct medical expenditures of children with asthma are 75-90% higher than those of children without asthma. In 2016, this amount totaled 40 billion dollars. Substantial indirect costs are incurred when parents miss work to care for their children who miss school. These additional costs raise the total economic burden of asthma to $80 billion annually. Frequent asthma-related school absences impair academic achievement and social functioning. This burden falls disproportionately on minority, low-income, and urban populations. For example, black children have 60% more ED visits and 75% more hospitalizations than white children even though they have similar asthma attack rates.
Adherence to ICS is notoriously poor.20, 22, 23 While 86% of privately insured patients who receive an ICS prescription will refill it within 30 days, only 64% will subsequently refill it again within 180 days. Even worse, only 3% will refill enough medication to cover greater than or equal to 75% of prescribed days with average medication possession being approximately 20%. Black and Hispanic patients are 20% less likely to refill their initial prescription and are 40% less likely to refill enough medication to cover greater than or equal to 75% of prescribed days. Adherence is similarly poor among the publicly insured. Among Medicaid-insured children, ICS is only refilled enough to cover 20% of prescribed days; fewer than 15% will refill enough to cover greater than or equal to 50% of days. At any given time, 40% of children with asthma are not well-controlled and much of this is attributable to nonadherence. Simulation and modeling studies suggest that maximizing ICS adherence among those prescribed ICS could reduce health care utilization by 25-45%. Even greater reductions are hypothesized if ICS prescribing could be expanded to all patients at risk of serious asthma-related exacerbations. However, a recent Cochrane review concluded that current methods of improving adherence for chronic health problems are mostly complex and not very effective. New adherence strategies will be needed if society is to achieve the gains suggested possible by simulations. Medication non-adherence among patients with chronic disease is a multi-dimensional challenge. The cost and convenience of obtaining medication (health system factors) and the motivation needed to adhere with a daily health habit (patient-related factors) are common barriers to adherence that are addressed by this study. Medication acquisition costs deter patients from refilling and refilling prescription medications. Even small $1-3 co-payments can appreciably reduce adherence. However, imposing additional time costs by requiring more frequent refills has an even greater impact. Time costs can add $50-100 per prescription. Therefore, the $155 out-of-pocket spending estimate for children's asthma medication likely understates the true economic burden. Dispensing ICS in the ED is therefore expected to improve adherence by reducing the substantial time and travel costs associated with medication acquisition. ICS treatment also burdens patients by requiring them to adopt a daily health habit. For children, this burden primarily falls on parents. Parents weigh the perceived benefits of treatment against their perceptions of treatment risk and burden. Given that asthma symptoms fluctuate in response to treatment and season, many purposefully reduce medication administration when their child's symptoms wane (volitional non-adherence).
In the absence of treatment, the underlying inflammation is allowed to worsen and exacerbation risk increases. This reactive pattern of medication use is substantiated by the fact that 37% of all prescriptions for ICS are refilled on the same day as prescriptions for oral corticosteroid, suggesting after the exacerbation, not before it.18 Even more disturbing, less than 50% of children who refilled a prescription for oral corticosteroid were ever noted to have refilled an ICS prescription, meaning most lacked any access to controller medication.18 Our proposal addresses the problem of primary non-adherence by dispensing medication in the ED and addresses non-adherence by arranging supervised use in the school setting.
- Conditions
- Asthma, Asthma in Children
- Being tested
- ED-Dispensing home and school supervision
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-Dispensing home and school supervisionDrug
- Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department),
- 360 ug of budesonide inhalation powder once-daily for at-home use, and
- albuterol sulfate as needed for relief of acute respiratory symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | ED-Dispensing with home and school supervision Receives: Drug: ED-Dispensing home and school supervision |
| Control | Other | ED-Dispensing with home supervision Receives: Drug: ED-Dispensing home and school supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Emergency Department (ED) Recidivism
90-day Emergency Department (ED) Recidivism as measured by the number of participants that return to the ED for asthma exacerbation within 90 days of discharge
Measured: 90 days
Secondary outcomes (1)
Cost-effectiveness
Cost-effectiveness as estimated by the dollars per averted ED visit
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Aug 2019
- Primary completion30 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Group 1 receives the intervention: ED-Initiated School-based Asthma Medication Supervision (school and home asthma medication supervision). Group 2 receives usual care (home asthma medication supervision).
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952286
- Sponsor's protocol ID
- 1R34HL137851
- Acronym
- EDSAMS
- Status last verified
- May 2022
- First submitted
- 3 May 2019
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gerald LB, Gerald JK, VanBuren JM, Lowe A, Guthrie CC, Klein EJ, Morrison A, Startup E, Denninghoff K. Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS). Pilot Feasibility Stud. 2021 Sep 27;7(1):179. doi: 10.1186/s40814-021-00913-0.
PubMed 34579785
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED-Initiated School-based Asthma Medication Supervision
- ClinicalTrials.gov ID
- NCT03952286
- Acronym / sponsor ID
- EDSAMS / 1R34HL137851
- Conditions
- Asthma, Asthma in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is a common chronic condition that causes substantial morbidity among children and much of it is attributable to medication non-adherence. The National Asthma Education and Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have urged others to develop more effective adherence programs.Schools are a logical setting to deploy such interventions because they are where children congregate, spend much of their day, and are frequently monitored. Because many schools serve a high proportion of minority and low-income students, engaging them presents a unique opportunity to reach populations who experience the greatest burden of preventable morbidity.
Supervising inhaled corticosteroid (ICS) use in the school setting can increase medication adherence and reduce episodes of poor asthma control. Under certain conditions, it can also be cost-effective. However, recruiting children from school settings tends to enroll children with mild asthma and infrequent health care use. Therefore, initiating supervised treatment in these children tends to burden school personnel with unnecessary work and diminishes the program's cost-effectiveness. To address this inefficiency, the investigators propose to recruit children who are discharged from the Hospital Emergency Departments (EDs) following successful treatment of an asthma attack. Such children have much higher risk of a future asthma attack than their peers.
The Pediatric Emergency Care Applied Research Network (PECARN) com- prises10 hospital-affiliated EDs that serve 1 million acutely ill and injured children annually. Their primary research mission is to reduce childhood morbidity and mortality by establishing creative partnerships between emergency medical service providers and their surrounding communities. The networks size and geographic diversity make it uniquely situated to develop, implement, and evaluate the feasibility and effectiveness of ED-Initiated School-Based Asthma Medication Supervision (ED-SAMS).
Approximately one-third of children treated for an asthma attack within PECARN experience a second ED-managed attack within 6 months. While the NAEPP guidelines recommend that long-term ICS treatment should be initiated at ED discharge, <20% of children actually receive a prescription for controller therapy. Observational data indicate that patients who use ICS following discharge are almost half as likely as non-users to experience a repeat ED visit. Many have also argued that ED-initiated treatment could be cost-effective. However, simply providing patients with a prescription does not ensure that they will actually use it once discharged. To ensure better medication adherence, the investigators propose to dispense ICS at discharge and supervise its use in the school setting.
Detailed description
Approximately 8% of children in the United States have asthma. Each year, these children experience 4 million asthma attacks that result in 725,000 ED visits and 100,000 hospitalizations. Unsurprisingly, the direct medical expenditures of children with asthma are 75-90% higher than those of children without asthma. In 2016, this amount totaled 40 billion dollars. Substantial indirect costs are incurred when parents miss work to care for their children who miss school. These additional costs raise the total economic burden of asthma to $80 billion annually. Frequent asthma-related school absences impair academic achievement and social functioning. This burden falls disproportionately on minority, low-income, and urban populations. For example, black children have 60% more ED visits and 75% more hospitalizations than white children even though they have similar asthma attack rates.
Adherence to ICS is notoriously poor.20, 22, 23 While 86% of privately insured patients who receive an ICS prescription will refill it within 30 days, only 64% will subsequently refill it again within 180 days. Even worse, only 3% will refill enough medication to cover greater than or equal to 75% of prescribed days with average medication possession being approximately 20%. Black and Hispanic patients are 20% less likely to refill their initial prescription and are 40% less likely to refill enough medication to cover greater than or equal to 75% of prescribed days. Adherence is similarly poor among the publicly insured. Among Medicaid-insured children, ICS is only refilled enough to cover 20% of prescribed days; fewer than 15% will refill enough to cover greater than or equal to 50% of days. At any given time, 40% of children with asthma are not well-controlled and much of this is attributable to nonadherence. Simulation and modeling studies suggest that maximizing ICS adherence among those prescribed ICS could reduce health care utilization by 25-45%. Even greater reductions are hypothesized if ICS prescribing could be expanded to all patients at risk of serious asthma-related exacerbations. However, a recent Cochrane review concluded that current methods of improving adherence for chronic health problems are mostly complex and not very effective. New adherence strategies will be needed if society is to achieve the gains suggested possible by simulations. Medication non-adherence among patients with chronic disease is a multi-dimensional challenge. The cost and convenience of obtaining medication (health system factors) and the motivation needed to adhere with a daily health habit (patient-related factors) are common barriers to adherence that are addressed by this study. Medication acquisition costs deter patients from refilling and refilling prescription medications. Even small $1-3 co-payments can appreciably reduce adherence. However, imposing additional time costs by requiring more frequent refills has an even greater impact. Time costs can add $50-100 per prescription. Therefore, the $155 out-of-pocket spending estimate for children's asthma medication likely understates the true economic burden. Dispensing ICS in the ED is therefore expected to improve adherence by reducing the substantial time and travel costs associated with medication acquisition. ICS treatment also burdens patients by requiring them to adopt a daily health habit. For children, this burden primarily falls on parents. Parents weigh the perceived benefits of treatment against their perceptions of treatment risk and burden. Given that asthma symptoms fluctuate in response to treatment and season, many purposefully reduce medication administration when their child's symptoms wane (volitional non-adherence).
In the absence of treatment, the underlying inflammation is allowed to worsen and exacerbation risk increases. This reactive pattern of medication use is substantiated by the fact that 37% of all prescriptions for ICS are refilled on the same day as prescriptions for oral corticosteroid, suggesting after the exacerbation, not before it.18 Even more disturbing, less than 50% of children who refilled a prescription for oral corticosteroid were ever noted to have refilled an ICS prescription, meaning most lacked any access to controller medication.18 Our proposal addresses the problem of primary non-adherence by dispensing medication in the ED and addresses non-adherence by arranging supervised use in the school setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 receives the intervention: ED-Initiated School-based Asthma Medication Supervision (school and home asthma medication supervision). Group 2 receives usual care (home asthma medication supervision).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: ED-Dispensing home and school supervisionED-Dispensing with home and school supervision |
| Control | Other | Drug: ED-Dispensing home and school supervisionED-Dispensing with home supervision |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 6-12 years of age; AND
- Treated for an asthma exacerbation as determined clinically by the principal ED provider based on symptoms such as shortness-of-breath, cough, and wheezing; AND
- Symptoms must improve following more than 1 dose of albuterol and more than 1 dose of systemic corticosteroids such that he/she can be safely discharged home; AND
- Must have physician-diagnosed
Key exclusion criteria (11 listed)
- Attends a non-participating school; OR
- Attends a participating school less than 5x/week; OR
- Enrolled in another research study; OR
- Patients who are hospitalized; OR
- The patient or their consenting parent/guardian does not speak English or Spanish; OR
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 |
|---|---|---|
| ED-Dispensing home and school supervision1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms. | Drug | Control, Intervention |
Primary outcome
90-day Emergency Department (ED) Recidivism
Time frame: 90 days
90-day Emergency Department (ED) Recidivism as measured by the number of participants that return to the ED for asthma exacerbation within 90 days of discharge
1 secondary outcome
Cost-effectiveness
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34579785Gerald LB, Gerald JK, VanBuren JM, Lowe A, Guthrie CC, Klein EJ, Morrison A, Startup E, Denninghoff K. Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS). Pilot Feasibility Stud. 2021 Sep 27;7(1):179. doi: 10.1186/s40814-021-00913-0.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
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 ED-Dispensing home and school supervision in people with Asthma and Asthma in Children, run by University of Arizona at 1 site in United States.
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 11 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 19 Nov 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
90-day Emergency Department (ED) Recidivism (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952286, which also lists 1 linked publication.
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 19 Nov 2025.