AsthmaNCT03032744
Aligning With Schools To Help Manage Asthma (Project ASTHMA)
A study testing Asthma Assessment & Management and Asthma Education in people with Asthma, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among… Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma Assessment & Management and Asthma Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to Jun 2020
- Phase
- Interventional
- 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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Active asthma
- Diagnosed with asthma for at least 12 months
- Enrolled in the school-based health center
- Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma in the previous 12 months for asthma
Who cannot join
- Underlying heart or lung disease other than asthma
- Student has well controlled asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
John R. Oishei Children's Hospital
Buffalo, New York, 14203
About this study
Official title: Aligning With Schools To Help Manage Asthma
Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.
Read the detailed description
Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.
- Conditions
- Asthma
- Being tested
- Asthma Assessment & Management, Asthma Education, Controller medication at school
- Keywords
- Pediatric, School Based Health Center
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Assessment & ManagementOther
Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
Asthma EducationOther
Asthma education on medications
Controller medication at schoolOther
Students will receive the morning dose of their daily preventive asthma medication at school on school days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days. Receives: Other: Asthma Assessment & Management; Other: Asthma Education; Other: Controller medication at school |
| Usual Care | Active comparator | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. Receives: Other: Asthma Assessment & Management; Other: Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up
Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up
Measured: Baseline, 1-month, 3-month, 5-month, 7-month
Secondary outcomes (2)
Change in ACT Score From Baseline to 7-month Follow-up
Improvement in ACT (Asthma Control Test) score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control. Minimum value is 0. Maximum value is 27. Higher scores mean a better outcome. Scores less than 19 suggest not well-controlled asthma.
The change in ACT score from baseline to 7-month follow-up
Measured: Baseline, 1-month, 3-month, 5-month, 7-month
Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up
Improvement FEV1/FVC ratio on spirometry. Higher number is a better outcome. FEV1/FVC ratio is a calculation used in pulmonary function testing to help diagnose lung conditions, particularly obstructive and restrictive lung diseases. It represents the proportion of air a person can exhale in the first second of a forced expiration (FEV1 - forced expiratory volume in 1 second) compared to the total amount of air they can exhale with maximal effort (FVC - forced vital capacity).
The change in FEV1/FVC ratio from baseline to 7-month follow-up.
Measured: Baseline, 1-month, 3-month, 5-month, 7-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start17 Jan 2017
- Primary completionJul 2019
- Study completionJun 2020
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student \& family will be responsible to administer the evening dose \& both doses on non-school days.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Lucy Holmes, MD, State University of New York at Buffalo
- Investigators
- Lucy C Holmes, MD, MPH, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032744
- Sponsor's protocol ID
- IMPACT1
- Other IDs
- UL1TR001412
- Status last verified
- Jun 2026
- First submitted
- 24 Jan 2017
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmes LC, Orom H, Lehman HK, Lampkin S, Halterman JS, Akiki V, Supernault-Sarker AA, Butler SB, Piechowski D, Sorrentino PM, Chen Z, Wilding GE. A pilot school-based health center intervention to improve asthma chronic care in high-poverty schools. J Asthma. 2022 Mar;59(3):523-535. doi: 10.1080/02770903.2020.1864823. Epub 2021 Jan 6.
PubMed 33322963
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aligning With Schools To Help Manage Asthma
- ClinicalTrials.gov ID
- NCT03032744
- Acronym / sponsor ID
- IMPACT1
- Conditions
- Asthma
- Keywords
- Pediatric, School Based Health Center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.
Detailed description
Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student \& family will be responsible to administer the evening dose \& both doses on non-school days.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Asthma Assessment & Management, Other: Asthma Education, Other: Controller medication at schoolAll participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment \& management'), and receive the morning dose of their daily asthma controller medication at school on school days. |
| Usual Care | Active comparator | Other: Asthma Assessment & Management, Other: Asthma EducationAll participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Active asthma
- Diagnosed with asthma for at least 12 months
- Enrolled in the school-based health center
- Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma in the previous 12 months for asthma
Key exclusion criteria (2 listed)
- Underlying heart or lung disease other than asthma
- Student has well controlled asthma
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 |
|---|---|---|
| Asthma Assessment & ManagementAsthma Assessment \& Management based on NAEPP-EPR3 guidelines | Other | Intervention, Usual Care |
| Asthma EducationAsthma education on medications | Other | Intervention, Usual Care |
| Controller medication at schoolStudents will receive the morning dose of their daily preventive asthma medication at school on school days. | Other | Intervention |
Primary outcome
Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up
Time frame: Baseline, 1-month, 3-month, 5-month, 7-month
Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up
2 secondary outcomes
Change in ACT Score From Baseline to 7-month Follow-up
Time frame: Baseline, 1-month, 3-month, 5-month, 7-month
Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up
Time frame: Baseline, 1-month, 3-month, 5-month, 7-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33322963Holmes LC, Orom H, Lehman HK, Lampkin S, Halterman JS, Akiki V, Supernault-Sarker AA, Butler SB, Piechowski D, Sorrentino PM, Chen Z, Wilding GE. A pilot school-based health center intervention to improve asthma chronic care in high-poverty schools. J Asthma. 2022 Mar;59(3):523-535. doi: 10.1080/02770903.2020.1864823. Epub 2021 Jan 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lucy C Holmes, MD, MPH principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Assessment & Management and Asthma Education in people with Asthma, 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 4 inclusion and 2 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 24 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?
Yes. Results are posted in the registry (first posted 9 Feb 2026). 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?
Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up (time frame: Baseline, 1-month, 3-month, 5-month, 7-month). 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 NCT03032744, 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 24 Jun 2026.