Aligning With Schools To Help Manage Asthma
Phase: NA
Conditions: Asthma
Sponsor: State University of New York at Buffalo

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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Official Title: 
Aligning with Schools to Help Manage Asthma (Project 
ASTHMA) 
NCT number: 
NCT03032744 
Document Type: 
Study Protocol and Statistical Analysis Plan 
 
Date of the 
Document: 
7/16/19 
 
 
 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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Objectives 
To improve asthma-related symptoms and lung function through a school-based intervention designed to: 
1. Promote chronic medication adherence in children with persistent asthma  
2. Facilitate the optimal management of patients based on NAEPP-EPR3 (National Asthma 
Education and Prevention Program – Expert Panel Report 3) guidelines 
Hypotheses 
Children with persistent asthma who receive their morning dose of their regularly prescribed twice daily 
controller medication in school will have reduced asthma-related symptoms and improved lung function 
compared to those who do not receive their medications in schools 
Inclusion Criteria 
The study will target children diagnosed with asthma who attend a Buffalo Public School that has 
a School-based Health Center (SBHC).  
Inclusion criteria include: 
• A student at one of the targeted schools 
• Enrolled for care in the SBHC 
• Have a primary care provider other than the advanced practice provider (APP) at the SBHC 
(If the student does not have a primary care provider, he/she can be referred to practices in 
the area.  They would be eligible for enrollment if they have seen this provider at least once 
prior to enrollment) 
• 4-14 years old 
• Have had a physician or APP diagnosed asthma for at least 12 months 
• Have active asthma defined as any of the following in the previous 12 months 
o 
Parent or child talked to a doctor or other health care professional about child’s 
asthma 
o 
Taken any asthma medications 
o 
Experienced any asthma symptoms 
• Have persistent asthma (based on NAEPP-EPR3 classifications) OR 
   ≥ 2 courses of systemic steroids due to asthma in the previous 12 months  OR 
   ≥ 2 Emergency Department/urgent care visits for asthma in the previous 12 months  OR 
   ≥ 1 hospitalization for asthma in the previous 12 months 
 
Exclusion Criteria 
• 
Child is already on an appropriate controller medication, and well controlled 
• 
Child who already has plans to leave the current school before the end of the school year 
UNLESS child will be going to a school participating in Project ASTHMA 
• 
Child has a significant lung or heart disease other than asthma 
• 
Pregnant Teenager 
• 
The child’s primary physician has already ordered a controller medication be given to the 
child every morning at school 
 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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Eligibility Screening 
1) Initial identification of potential subjects will be through the school nurses and APPs who already 
know their population of children with asthma that they see for treatment in the SBHC.  The school 
APP at each of the schools currently have a list of students who have asthma.  The school APPs are 
health care providers for the children in their respective schools, and also are members of the study 
staff.  Potential subjects may also be identified by the providers at Niagara Street Pediatrics, Towne 
Garden Pediatrics, and UBMD Allergy & Immunology Clinics.  The study investigators are providers 
at these clinics.  Potential subjects may be identified by the providers at UBMD Lung Center Clinics.  
Potential subjects can also self-identify by seeing a Project ASTHMA flyer in the school or at 1 of the 
above clinics. 
2) Screening:  A screening will be conducted to determine if the prospective participant meets the 
eligibility criteria.  The eligibility criteria will be determined by self-report from the parent.  This can 
either be conducted (1) in person, when the parent/guardian expresses interest to a member of the 
research team, (2) over the phone, if a parent/guardian calls and/or is called based on their previously 
expressed interest in participating in the research study.  Investigators who are also the prospective 
participant’s provider may call a family who may meet inclusion criteria.  If a student does not meet 
the screening criteria, only their name will be recorded so the study team does not contact the parent 
of that child again. 
3) Enrollment:  All of the individuals who meet inclusion criteria will be asked to schedule an enrollment 
visit.  Consent will be obtained from all individuals who attend this session.   
Recruitment Methods 
1) The school APP, who is also an investigator, will send out letters to the parent of all the known 
children with asthma at the beginning of the school year to let them know about the study & their 
potential eligibility.  These letters may be sent home with the student, or mailed to the parent.  If 
mailed, the records of the students will be reviewed in order to obtain the parent address. The 
student’s health record may also be reviewed to confirm the asthma diagnosis. The letter will provide 
the parents with information about the study prior to the APP speaking with them.  This letter will also 
provide contact information for the parent to call the APP or research coordinator for more information 
about the study.   
2) Prescription Drop-off:  All of a student’s medication for school, including rescue inhalers for asthma, 
must be hand delivered to the school nurse’s office at the beginning of the school year.  We plan to 
have a recruitment flyer, information sheet, and contact sign-up sheet present in the school nurses’ 
offices for parents to see when they arrive.  The research coordinator also may be in the school 
nurses’ office to answer parents’ questions after they have expressed interest. 
3) Phone calls to parents:   
a. If the school APP needs to call a parent because she saw the child in the SBHC (part of their 
routine care), and the child has asthma, she may let the parent know about Project ASTHMA & 
ask if the parent is interested in learning more about the study.   
b. Investigators who are also the student’s provider, may pre-screen charts to determine if the 
patient may be eligible for the study.  If they are potentially eligible, the investigator-provider may 
contact the family by phone to ask if they would be interested in participating in the study.  
c. If the APP identifies a student as a potential participant, and they are also a patient of one of the 
investigators or one of the practices who have provided Project ASTHMA with a letter of support, 
the potential subjects’ provider may also be asked to contact the family regarding the study. In 
that case, the child’s name, school, and individual they last saw in the clinic will be recorded and 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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shared with the provider either via secure electronic communication or person-to-person 
communication. The provider may access the individual’s medical record in order to find the 
appropriate phone number and contact the family to ask about their interest in participating in 
Project ASTHMA. All providers are familiar with the overall study and HIPAA privacy laws. 
4) Flyer:  Flyers will be placed in the participating schools, Niagara Street Pediatrics, Towne Gardens 
Pediatrics, the UBMD Allergy & Immunology Clinics, and the Lung Center Clinics so that individuals 
may also self-identify.  It is possible that not all children with asthma in the schools are known to the 
SBHC, because (1) students and their families must enroll in the SBHC separately from regular 
school services and can only be seen by the SBHC personnel if they are enrolled in the SBHC, and 
(2) not all children come to the nurses office when they have asthma symptoms.  If parents/guardians 
express interest in participating in the study and their children are not already enrolled in the SBHC, 
they will be told that they can participate if they choose to enroll their children in the SBHC.  Flyers 
may also be sent home with the students at the schools who are enrolled in the SBHC and known to 
have asthma. 
5.) If the investigator or another study team member sees a patient in their clinic who may meet the study 
requirements, and is informed by the patient or family that they attend one of the schools that 
participates in our study, the study team member may inform the family about the study and provide 
an information sheet and/or ask for their permission for a member of the study staff to contact them to 
provide more information about the study.  
6.) If the patient is seen at Niagara Street Pediatrics, Towne Garden Pediatrics, or Allergy/Immunology 
Clinic by a provider who is not a study investigator, and during the course of a clinic appointment this 
provider notes that the patient has asthma and fits the age range for the study, this provider can give 
the parent of the patient a study flyer to read.  They can ask the parent if the Project ASTHMA 
research coordinator may contact them.  If the parent is interested in hearing more about the study, 
they will be provided an envelope (addressed to the Project ASTHMA team) with a form for them to 
complete, giving the study team permission to contact them.  After completing the form, the parent 
will be instructed to place it back in the envelope & seal it.  The envelope will be forwarded to the 
research coordinator. 
7.) Lung Center Clinics – Potential study patients may be seen by providers at the Lung Center.  If during 
the course of a clinic appointment, the Lung Center provider notes that a patient has asthma and fits 
the age range for the study, the Lung Center provider can give the parent of the patient a study flyer 
to read.  They can ask the parent if the Project ASTHMA research coordinator may contact them.  If 
the parent is interested in hearing more about the study, they will be provided an envelope 
(addressed to the Project ASTHMA team) with a form for them to complete, giving the study team 
permission to contact them.  After completing the form, the parent will be instructed to place it back in 
the envelope & seal it.  The envelope will be forwarded to the research coordinator.  
8.)  Community Physicians – Physicians who care for children who may attend the target schools, 
including the physicians who have already provided letters of support for this study, will be given 
study flyers to give to potential enrollees.  Interested parents can contact the research coordinator. 
9.) Tabling sessions: Additional school events, such as parent-teacher-conference days or school open 
houses may also be utilized as recruitment opportunities. If this occurs, the same processes will be 
used as if the parent presented in the SBHC to drop off medications 
Please note that the recruitment strategies are listed in the order in which we intend to use them and 
preference on how we will recruit.  The later options will be used in the event that we do not meet the 
recruitment goals using the earlier strategies.    
 
 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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Procedures: 
1.) Enrollment Visit:  
After a potential subject meets the screening criteria, an enrollment visit will be scheduled at the 
SBHC.  If the parent/guardian is unable to come to the SBHC, arrangements will be made for a home 
visit by the research coordinator to enroll the student. In this situation, the medical questions will be 
asked by the APP over the phone. The enrollment visit includes many steps, and the medical portion 
is similar to what would occur if the patient presented to their doctor’s office for a visit for their 
asthma.  This visit will include the following listed procedures and should take approximately 1 hour to 
complete.  
a. Parental Permission and child Assent will be obtained 
i. Includes request to contact child’s Primary Care Provider  
ii. Includes request to contact child’s allergist and/or pulmonologist, if applies 
b. History: All of the demographic and history questions will be asked verbally by the individual 
conducting the assessment and recorded on paper. 
i. Initial Data form 
ii. Asthma Control Test (ACT) Form:  The ACT questionnaires are a validated tools used 
regularly for asthma patients.  In addition, the results are included in the NAEPP-EPR-3 
Guidelines for the assessment of asthma control for children ≥12.  Although this is 
typically filled out by the parents and children on their own in the clinic setting, the 
validated process requires an explanation of the questions.  In order to ensure that the 
patients understand all questions as they were designed to be answered, they will be 
read and explained by the research personnel.  Children 4 to 11 have slightly different 
questions on their ACT form than children 12 and older. 
c. MDI Spacer Training & medication training:  All patients are to be educated on the use of their 
controller inhalation medication and their spacer devices.  Patients are assessed on how they use 
the items and then advised on proper technique, why it is important, and what they can improve 
on in the future.  We will also provide the subjects and their parents with printed education 
material on the proper use of a spacer.  
d. Other education:  The student subjects and their families will be provided with education on the 
benefits of daily asthma medication use (using visual aids) and the effects of smoking on asthma.   
e. Spirometry breathing test:  Spirometry tests are routinely performed by allergy specialists and 
pulmonologists.  The NAEPP-EPR3 recommends this test also be performed in primary care 
offices to improve the care of patients with asthma, although this practice has still not been widely 
adapted.  It is possible that some of the subjects may have had this test before the study. 
i. 
The test must be administered and interpreted by trained individuals.  The research 
coordinator will be trained on test administration and interpretation prior to study initiation.  
The APPs will be trained on test interpretation & how the results affect the child’s asthma 
disease classification.  There will be one study designated spirometer and laptop (the 
spirometer is associated with computer based programming that will be installed on the 
laptop and be used only for research). These are small, transportable objects that will be 
easily transported between the schools and the department of Pediatric offices. If 
unsuccessful in completing the spirometry test, or if the student was not eligible to 
complete spirometry at the visit (current asthma exacerbation, a significant upper 
respiratory infection, took a albuterol within 4 hours, took a LABA (Long-acting beta-
agonist) in the last 12 hours, or received oral steroids in the past 4 weeks), the spirometry 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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will not be repeated until the next follow-up assessment.  The APPs will assess child’s 
asthma severity based on the NAEPP-EPR-3 Guidelines. The subject’s asthma severity 
will be determined based on the most severe result and NAEPP-EPR3 step-wise 
guidelines. 
f.  For students 10 years old and older, both the parent & the student will be asked the questions 
on the frequency of the students’ asthma symptoms, & the agreed upon answer between the 2 of 
them will be recorded.  For students younger than 10 years old, only the parent will be asked 
these questions. 
2.) Eligible students 
Students are randomized based on a stratified block randomization (numbered, sealed envelopes with 
site specific randomizations will be located at each SBHC). 
a. Usual care:   
ii. 
Parents will be given the result of the asthma assessment & be told to have their child 
follow-up with his/her primary care provider (PCP) for further asthma management. 
iii. 
The student’s PCP will be sent a letter with the student’s asthma classification.  A copy 
of this letter will be sent to the child’s allergist and/or pulmonologist if applies. 
b. Intervention:   
i. 
Students will self-administer the morning dose of their controller medication under the 
guidance of the SBHC nurse who will also reinforce proper medication administration 
technique and home medication adherence. This will start at the time of enrollment and 
continue until the student’s last day of school in June, 2019.  Students & their parents 
will be responsible for administering the evening and non-school day doses of their 
medication at home.  The students will be asked each day they are in the health office 
if they remembered to take the previous evening’s home dose of their medication.  
Parents will be told at the final 7-month follow-up assessment that they should follow-
up with their child’s PCP within 1 month after the end of school year. 
ii. 
If as a result of the asthma assessment the study team determines the student should 
change their controller medication or change the dose of their controller medication, the 
PCP or specialist, if applies, will be contacted & a verbal agreement will be 
documented prior to prescribing the medication.  An exception to this would be if the 
PCP or specialist is the study investigator or part of the study investigator’s practice 
group (Niagara Street Pediatrics & Towne Garden Pediatrics).  Another exception 
would be if the PCP practice has provided Project ASTHMA with a written a letter of 
collaboration stating they support our medication management decisions and are 
satisfied with a letter providing them with our management decision after the 
medication change has been made.  A third exception would be if the enrollee is a 
patient of the allergist who is also a study investigator, in the UBMD 
Allergy/Immunology Clinics. 
iii. 
Parents will be given the result of the asthma assessment 
iv. 
Asthma Action Plan - An individualized Asthma Action Plan will be completed for the 
student & the study team member will review the directions on the AAP with the parent 
& the student 
v. 
 The student’s PCP will be sent a letter with the student’s asthma classification & the 
recommended step therapy based on NAEPP-EPR3 report.  A copy of this letter will be 
sent to the child’s allergist or pulmonologist if applies. 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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3.) Follow-up visits for all students: 
a. Follow-up asthma assessments will be done at 1-, 3- and 5-months after enrollment and a final 
follow-up assessment at 7-months after enrollment.  The 1-month visit may be done up to 2 
weeks later.  The 3-, 5- and 7-month follow-up visits may be done up to 2 weeks earlier or later.  
At the 1-, 3- and 5-month follow-ups, students will be seen in the SBHC, complete the patient 
questions on the ACT form, and have spirometry performed.  At the 1-, 3- and 5-month follow-
ups, the research coordinator will call the parent/guardian to complete the follow-up data form & 
the parent questions on the ACT form by phone.  At the 7-month final follow-up assessment, both 
the parent/guardian & student will be seen in the SBHC to complete the final assessment.  The 
final assessment will include the (1) follow-up data form, (2) ACT form (3) the same asthma 
education given at enrollment, and (4) spirometry testing.  If the parent/guardian cannot come to 
the SBHC to complete the questionnaires, they will be administered by phone by the research 
coordinator.  In this situation, only the student will receive the repeated asthma education. 
b. For students 10 years old and older, both the parent & the student will be asked the questions on 
the frequency of the students’ asthma symptoms.  Since they will not be together when these 
questions are asked at the 1-, 3- and 5-month follow-ups (the students will be asked in the SBHC, 
while the parents will be asked over the phone), the answers may be different.  For the purpose 
of determining the Control Classification, we will use the higher of the 2 answers.  If both the 
parent and the student are present at the final, 7-month follow-up, we will use their agreed upon 
answers to determine the Control Classification.  For students younger than 10 years old, only the 
parent will be asked the symptom frequency questions at all the follow-up visits. 
c. The Research Coordinator will arrange the follow-up visits.  Each child may attempt the 
spirometry test up to 3 times at the follow-up assessments if the initial readings were not 
interpretable but the research coordinator feels the child may be able to achieve an interpretable 
curve if repeated on another day.  The 1- and 3-month follow-up visits should take about 15 
minutes for the student & 10 minutes for the parent/guardian to complete.  The final follow-up visit 
should take about 30 minutes to complete. A letter with the student’s results will be sent to the 
child’s PCP after each asthma assessment.  A copy of this letter will be sent to the child’s allergist 
or pulmonologist if applies. 
 
4.) Intervention group: 
The SBHC APP will write the prescriptions for the controller medication to make sure the child has the 
medication at home and at school.  This type of care is part of the APPs regular job activities.  
a. Choice of Medication: 
There are 2 categories of controller medications.  This includes inhaled corticosteroids (ICS) and 
combination ICS plus LABA.  The medications included in each category include: 
Inhaled dosages 
(1) Alvesco HFA (FDA approved ≥12 years old) 
(2) ArmonAir RespiClick (FDA approved ≥12 yrs old) 
(3) Asmanex HFA (FDA approved ≥12 yrs old) 
(4) Asmanex Twisthaler (FDA approved ≥4 yrs old) 
(5) Flovent Diskus (FDA approved ≥4 yrs old) 
(6) Flovent HFA (FDA approved ≥4 yrs old) 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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(7) Pulmicort Flexhaler (FDA approved ≥6 yrs old) 
(8) Qvar Redihaler (FDA approved ≥4 yrs old) 
 
Combination Inhaled Corticosteroid Plus LABA 
(1) Advair Diskus (FDA approved ≥4 yrs old) 
(2) Advair HFA (FDA approved ≥12 yrs old) 
(3) AirDuo RespiClick (FDA approved ≥12 yrs old) 
(4) Dulera HFA (FDA approved ≥12 yrs old) 
(5) Symbicort HFA (FDA approved ≥6 yrs old) 
b. We will be following the NAEPP-EPR3 guidelines on medication drug dosing.  Students 
meeting the criteria for step 2 therapy will be placed on low-dose ICS.  Students meeting the 
criteria for step 3 therapy will be placed on medium dose ICS.  Students meeting the criteria 
for step 4 therapy will be placed on a combination medium dose ICS plus LABA.  Students 
who are followed by an Allergy or Pulmonary specialist & placed on a combination high dose 
ICS plus LABA by this specialist will be maintained on the same drug. 
c. Flovent is the most commonly prescribed inhaled corticosteroid by pediatricians and pediatric 
subspecialists who manage asthma in our community, and so this will be our preferred drug 
to use for step 2 and 3 therapy.  If the student’s insurance does not cover Flovent, we will 
choose another inhaled corticosteroid based on the drug that is approved by the student’s 
insurance company & has the FDA approval for the age of the child. 
d. Advair and Symbicort are the most commonly prescribed combination inhaled corticosteroid 
plus LABA and so will be our preferred drug to use for step 4 and 5 therapy.  If the student’s 
insurance does not cover these drugs, we will choose another inhaled corticosteroid based 
on the drug that is approved by the insurance company & has the FDA approval for the age 
of the child.  The one exception to this would be Advair HFA which has FDA approval for 
children 12 years of age and older.  Advair Diskus has FDA approval for children 4 years of 
age and older.  Advair HFA and Advair Diskus have the same active ingredients, fluticasone 
propionate and salmeterol.  The only difference is the mechanism of delivery.  Although 
Advair HFA is not FDA approved in children 4 to 11 years of age, the active ingredients and 
the HFA propellant are FDA approved in children 4 years of age and older.  Young children 
are unable to adequately demonstrate the proper technique to use the Diskus device and get 
adequate delivery of the drug into their lungs.  The Advair HFA uses a metered dose inhaler 
device, and with the use of a value holding chamber, this is the preferred device to use in 
young children to ensure adequate delivery of the drug to the lungs.  We have obtained an 
IND exemption to use Advair HFA in this study in children 4 years of age and older. 
e. After the initial assessment, all students in the intervention group will fall into 1 of the 
following categories: 
1. continued on the same controller medication and dose as previously prescribed by their 
PCP or specialist, if applicable 
2.  started on a controller medication at the appropriate step therapy 
3.  step-up to a higher step therapy than previously prescribed by their PCP or specialist, if 
applicable 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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If #3 applies, the student’s PCP or specialist, if applies, will be contacted to obtain verbal 
agreement for the change in medication and/or dose unless any of the following applies: 
i. 
PCP is from Niagara St Pediatrics or Towne Garden Pediatrics 
ii. 
PCP is from a practice for which Project ASTHMA has a letter of collaboration 
iii. 
Student is a patient of UBMD Allergy/Immunology or Pulmonary 
f. 
Since this is a health services trial, and the student’s provider (the SBHC APP, the PCP or 
the specialist) has determined that the student should be on a controller medication, we will 
be obtaining the medications from the child’s health insurance.  
g. Medication Access:  
i. 
Second Controller: The number of inhalers allowed at one time varies by insurance 
companies. Some insurance companies will only approve 1 inhaler of a daily 
controller medication per month (1 month’s supply) and others will approve up to 
three inhalers for a three-month supply.  This protocol requires the release of three 
controllers at once - 1 to be kept in the school nurse’s office for administration of the 
morning dose, and 2 to be kept at home for all other doses.  By obtaining 3 inhalers 
at once, the school inhaler will have enough doses for at least 3 months and the 2 
home inhalers will have enough doses for 3 months.  Once 3 months pass, we can 
then order another 3 inhalers for the next 3 months.   
ii. 
Insurance Companies:  As part of standard care, a prior approval for additional 
controller medications can be submitted by a provider who determines it is beneficial 
for their patient to receive his/her medication at school. Since this is a health 
services trial, the sustainability of the intervention hinges on the successful 
incorporation of existing systems, including the health insurance system.  We 
therefore feel it is important to use the student’s health insurance to supply the 
medication, as it would be required to do so if the school APP ordered this outside 
of the study.  
iii. 
Asthma controller medications come in 2 forms, a metered dose inhaler (MDI) and 
dry powder inhaler (DPI).  Young children are unable to use the DPI form well 
enough to achieve adequate delivery of the drug to their lungs.  They therefore 
require the use of the MDI form with a spacer device.  Some insurance formularies 
only have the DPI.  As part of standard care, a prior approval for an MDI controller 
can be submitted by a provider who determines his/her patient requires this.  We will 
be using this same process in the study. 
iv. 
It is not expected that there will be any added medication cost to the subject’s 
families because (1) our target population is from low-income communities and have 
managed Medicaid so they do not have co-pays for their medications, and (2) for 
those families who do have private insurance & must pay a co-pay for their 
medications, they will still have the same number of co-pays over the course of the 
intervention because each canister will last more than 1 month. 
v. 
For patients who do not have insurance or their insurance will not allow them to 
receive more than 1 controller medication within 1 month, we will have some sample 
medications for their use. 
vi. 
Transport to school: Prescriptions for controller medications will be sent to Oishei’s 
Children’s Hospital pharmacy or to the family’s preferred pharmacy.  The research 
coordinator will pick up the medications that will be used in the school.  If more than 

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
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1 controller is filled at once, the research will pick up all medications prescribed and 
ask the parent to come to the school to pick up the inhalers for home use.  If the 
parent picks up the medications from the pharmacy, they will be responsible for 
bringing the inhaler that will be used in school to the SBHC. 
h. Medication Administration:  
i. 
The APPs, who are also the students’ health care provider, will write the order for the 
controller medication to be given at school.  All children in the intervention group will 
be asked to come to the nurse’s office in the morning on school days to take morning 
dose of their controller medication. 
ii. 
Although it is not often that children with asthma take their daily controller 
medications at school, the administration of student medications is part of the school 
nurses’ normal responsibility.  Under standard school nurses’ procedures, 
medications are delivered to the school (usually by the child’s parent) and medication 
is administered by either the APP or school nurse.  Every time a medication is given 
in the school, it must be recorded in the SBHC medication log. The log is considered 
a school record, but it is accessible to all members of the SBHC staff.  A member of 
the research team, either the SBHC APP or research coordinator, will use this log to 
confirm that the individuals in the study received their medications and as part of a 
process evaluation.  
iii. Each morning when the students are given their controller medication, the individual 
delivering the medicine will also ask if the student took the second (nighttime) dose of 
their medication the night before & remind them to take their medication at home.  
The answer to this question is not intended to obtain accurate data points, but will 
serve as a reminder for children to take their home doses of their controller 
medication.  The answer to this question will not be recorded. 
i. Medication change by PCP, allergist, or pulmonologist 
i. 
If at any time during the study period the student’s PCP, allergist, or pulmonologist 
wants the student to step-up in the strength of their asthma controller medication, the 
student can still stay in the study.  The provider making the change would be required 
to prescribe the controller medication for home & school use.   
j. Valve holding chamber (spacer) 
i. 
If the student does not have a spacer device at home, the APP will prescribe 1 for 
home use.  If the student does not already have a spacer device at school, the APP 
will prescribe 1 for school use & the research coordinator will pick this up from the 
pharmacy to bring to the school.  If the student’s insurance will not pay for the 2nd 
spacer, the student will be provided 1 for school use through study funds.   
k. Medication changes at follow-up visits:  
i. 
Any necessary adjustments to controller medication will be done at the time of each 
of the follow-up assessments.  If the child requires a change in medication, they will 
be given an updated AAP & a study team member will review the directions on it 
again.  All students in the intervention arm will receive a final AAP at the 7-month 
assessment. 
l. 
Study visit locations:  All study visits are expected to take place in the SBHC located in the 
schools.  If the parent or legal guardian is unable to come to the SBHC for enrollment, the 
research coordinator will conduct a home visit to enroll the student.   

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m. School changes:  Children whose parents report that they plan to move/leave the school 
before the end of the school year will be excluded from study participation.  However, based 
on the patient demographics and APP experience, we expect that there will be instances 
where children switch schools due to unexpected moves or other occurrences.  If this is the 
case, the following procedures will be followed:  
i.   Usual care group: 
Children will still be asked to follow-up with the study team for their 1-, 3-, 5- and 7-month 
follow-up visits.  In the event that a child in the usual care group leaves the school where 
they were originally enrolled and does not attend another participating school, they will be 
asked to return to the original school for their follow-up visits if they still live locally. If the 
child and parent are unable to come to school for the assessment, we will obtain the 
asthma health history via the phone or a home visit.  This process was approved by the 
Buffalo Public Schools.  
ii.  Intervention group:  
If the child moves to another school that is involved in the study, they can continue as a 
study participant 
iii. If the child moves to a school that is not currently participating in the intervention, then 
they will not be able to continue to participate in Project ASTHMA.  
n. Other loss to follow-up:  If the student is no longer at their school of enrollment and/or we are 
not able to contact the family and complete the follow-up visits, we will assess the child’s 
medical record to collect the study data points that can be ascertained from the medical 
record. 
o. Asthma Medication Assessments and Management 
i. 
The SBHC APP serve as both the providers for study patients and the study 
investigators.  They are part of the intervention in the study as well, as they are trained by the 
Principal Investigator to provide NAEPP-EPR3 guideline-based asthma assessment & 
management to their patients.  This training is not solely for study purposes, but can be 
applied to study & non-study patients, as well as be applied to their patients after the 
completion of the study.  As the study patient’s provider, the SBHC APPs can make asthma 
assessments and management decisions (prescribe medications), as part of their normal job 
responsibilities. 
ii. 
In the event that a SBHC APP/investigator leaves the intervention school, the new SBHC 
APP will receive NAEPP-EPR3 guideline-based asthma assessment & management training 
to apply to all her/his patients.  Since Project ASTHMA is a health services intervention, our 
goal is to use the existing health care system in an innovative way to improve the delivery of 
health care.  In providing chronic care management for their asthma patients, the SBHC 
APPs are performing their normal job responsibilities. 
Data Management and Analysis 
We expect children in the intervention group to have fewer asthma symptoms and exacerbations than 
children in the control group. To verify that there are no differences in potential confounders between the two 
groups, we will use chi-square and t-tests to identify any significant differences in caregiver education and 
health literacy, children’s exposure to second hand smoke, and BMI. We will include any variables for which 
there are significant group differences in all models. We will conduct both intent-to-treat and as-treated 
analyses.  

Project ASTHMA Study Protocol and Statistical Analysis Plan 7/16/19 
12 
 
Our primary outcome measure is the decrease in frequency of daytime asthma symptoms per week, over a 4-
week interval. We will measure asthma symptoms at baseline, 1-, 3- and 7-months, Our secondary outcome 
variables are scores on the continuous ACT scale. Another secondary outcome measure is improvements in 
spirometry scores (FEV1/FVC ratio).  We will use linear regression to test for differences in at baseline, 1-, 3- 
and 7-month ACT score controlling for baseline ACT score and any covariates that varied by group. We will 
repeat similar analyses for FEV1/FVC at baseline, 1-, 3- and 7-months controlling for baseline FEV1/FVC 
score.  
We will also model outcomes for number of courses of oral/parenteral steroids for asthma. We will test 
negative binomial regression models, individually regressing each of the health care usage variables on group 
(intervention vs. control). We will control for covariates that vary as a function of group.  
 
All spirometry tests will be interpreted by 1 of the investigators.  The allergy specialist on the study team will 
also evaluate the interpretability of each of the spirometry tests.