Childhood AsthmaPhase 4SAMSNCT01997463
Supervised Asthma Medication in Schools (SAMS)
A Phase 4 study testing Supervised asthma therapy in schools in people with Childhood Asthma, run by University of Arizona at 1 site in United States.
Trial summary
The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- Supervised asthma therapy in schools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2016
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A child with asthma attending a Tucson Unified School District elementary school selected for the study.
Who cannot join
- No asthma.
- Not attending a Tucson Unified School District elementary school selected for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona and the Tucson Unified School District
Tucson, Arizona, 85724
About this study
Official title: The Cost Effectiveness of School-Based Supervised Asthma Therapy
The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.
Read the detailed description
This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.
- Conditions
- Childhood Asthma
- Being tested
- Supervised asthma therapy in schools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised asthma therapy in schoolsDrug
Also called Inhaled Corticosteroid, Ventolin
Therapy observed daily in school. Asthma education by American Lung Association
| Study group | Role | What they receive |
|---|---|---|
| Regular Therapy | No intervention | Regular Asthma Therapy |
| Supervised Therapy | Experimental | Supervised asthma therapy in schools Receives: Drug: Supervised asthma therapy in schools |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
An ACQ score of > 1.5 means asthma is not well controlled. An ACQ score of <= 1.5 means asthma is well controlled.
Missing ACQ score = number of participants not administered an ACQ
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
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 Childhood 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lynn B Gerald, Ph.D., MSPH, Principal investigator, University of Arizona, Mel and Enid Zuckerman College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997463
- Sponsor's protocol ID
- 1200000709
- Other IDs
- 1R18HL110858
- Acronym
- SAMS
- Status last verified
- Feb 2022
- First submitted
- 22 Nov 2013
- Last updated
- 23 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC, Bryson D, Stefan N, Billheimer D, Gerald LB. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019 Feb;143(2):755-764. doi: 10.1016/j.jaci.2018.06.048. Epub 2018 Aug 14.
PubMed 30118728
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost Effectiveness of School-Based Supervised Asthma Therapy
- ClinicalTrials.gov ID
- NCT01997463
- Acronym / sponsor ID
- SAMS / 1200000709
- Conditions
- Childhood Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 23 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.
Detailed description
This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Therapy | No intervention | –Regular Asthma Therapy |
| Supervised Therapy | Experimental | Drug: Supervised asthma therapy in schoolsSupervised asthma therapy in schools |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A child with asthma attending a Tucson Unified School District elementary school selected for the study.
Key exclusion criteria (2 listed)
- No asthma.
- Not attending a Tucson Unified School District elementary school selected for the study.
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 |
|---|---|---|
| Supervised asthma therapy in schoolsAlso: Inhaled Corticosteroid, VentolinTherapy observed daily in school. Asthma education by American Lung Association | Drug | Supervised Therapy |
Primary outcome
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Time frame: 1 year
An ACQ score of > 1.5 means asthma is not well controlled. An ACQ score of <= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30118728Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC, Bryson D, Stefan N, Billheimer D, Gerald LB. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019 Feb;143(2):755-764. doi: 10.1016/j.jaci.2018.06.048. Epub 2018 Aug 14.
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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.
Lynn B Gerald, Ph.D., MSPH principal investigator
University of Arizona, Mel and Enid Zuckerman College of Public Health
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 Supervised asthma therapy in schools in people with Childhood Asthma, 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 1 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 23 Mar 2022. 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 23 Mar 2022). 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?
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) (time frame: 1 year). 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 NCT01997463, 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 23 Mar 2022.