Asthma in ChildrenNCT06539312
Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes
A study testing APP assessment and management of asthma in people with Asthma in Children and Directly Observed Therapy, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Asthma in Children, Directly Observed Therapy
- What is being tested?
- APP assessment and management of asthma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 30 Apr 2028
- 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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- uncontrolled asthma
Who cannot join
- other chronic lung disease such as cystic fibrosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo, Department of Pediatrics
Buffalo, New York, 14203
Lucy Holmes, MD, MPH, 716-323-0034, LHolmes@upa.chob.edu
About this study
Official title: Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.
- Conditions
- Asthma in Children, Directly Observed Therapy
- Being tested
- APP assessment and management of asthma
- Keywords
- Asthma, Children, School-based health center, NIH Guideline-based care, Controller medication, Directly Observed Therapy
- Medical subject headings
- Directly Observed Therapy, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP assessment and management of asthmaOther
Also called DOT of morning dose of controller medication
APPs will be trained to follow NIH guidelines for assessment and management of asthma, and to apply their knowledge to the care of the students. Students will also receive DOT of the morning dose of their controller medication.
| Study group | Role | What they receive |
|---|---|---|
| SBHC group | Experimental | Not described Receives: Other: APP assessment and management of asthma |
| PCP group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbations
Number of asthma exacerbations requiring systemic steroids based on medical records
Measured: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Secondary outcomes (10)
Daytime asthma symptoms
Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome.
Measured: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Nighttime asthma symptoms
Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome.
Measured: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1
Forced Expiratory Volume in 1 second
Measured: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1/FVC ratio
FEV1/Forced Vital Capacity ratio
Measured: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
ED visits
Number of ED visits for asthma symptoms based on medical records
Measured: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Urgent care visits
Number of urgent care visits for asthma symptoms based on medical records
Measured: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Hospitalizations
Number of hospitalizations based on medical records
Measured: from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.
Quality of Life - caregiver
Children's Health Survey for Asthma, American Academy of Pediatrics Higher scores mean a better outcome.
Measured: to be assessed at baseline and at 7-month follow-up for 1 school year
Activity Limitation
Degree of activity limitation based on questionnaire Higher scores mean a worse outcome.
Measured: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
school absenteeism
Number of missed school days based on school records
Measured: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start27 Sep 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Lucy Holmes, MD, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539312
- Sponsor's protocol ID
- STUDY00007712
- Other IDs
- R01MD018384
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities
- ClinicalTrials.gov ID
- NCT06539312
- Acronym / sponsor ID
- STUDY00007712
- Conditions
- Asthma in Children, Directly Observed Therapy
- Keywords
- Asthma, Children, School-based health center, NIH Guideline-based care, Controller medication, Directly Observed Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 6 Aug 2024 (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.
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBHC group | Experimental | Other: APP assessment and management of asthma |
| PCP group | No intervention | – |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- uncontrolled asthma
Key exclusion criteria (1 listed)
- other chronic lung disease such as cystic fibrosis
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 |
|---|---|---|
| APP assessment and management of asthmaAlso: DOT of morning dose of controller medicationAPPs will be trained to follow NIH guidelines for assessment and management of asthma, and to apply their knowledge to the care of the students. Students will also receive DOT of the morning dose of their controller medication. | Other | SBHC group |
Primary outcome
Asthma exacerbations
Time frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Number of asthma exacerbations requiring systemic steroids based on medical records
10 secondary outcomes
Daytime asthma symptoms
Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Nighttime asthma symptoms
Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1
Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1/FVC ratio
Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
ED visits
Time frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Urgent care visits
Time frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Hospitalizations
Time frame: from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.
Quality of Life - caregiver
Time frame: to be assessed at baseline and at 7-month follow-up for 1 school year
Activity Limitation
Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
school absenteeism
Time frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
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 25 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP assessment and management of asthma in people with Asthma in Children and Directly Observed Therapy, run by State University of New York at Buffalo 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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.
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 Lucy CY Holmes, MD, MPH (716-323-0034, LHolmes@upa.chob.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma exacerbations (time frame: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.). 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 25 Jun 2026.