Asthma in ChildrenPRAGMATIC-SNCT07224061
Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
A study testing PRAGMATIC-S in people with Asthma in Children, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- PRAGMATIC-S
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 30 Jun 2033
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician-diagnosed asthma documented in EHR
- Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, >2 days/week with symptoms, >2 days/week using rescue medication, >2 days/month with nighttime symptoms, or >2 episodes/year that required systemic corticosteroids
- Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers)
- Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
- Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected.
- Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF
Who cannot join
- Family plans to leave school or city within 6 months
- Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease)
- Children in foster care or other situations in which consent cannot be obtained from a legal guardian
- Participation in concurrent asthma intervention study
- Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire
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
Children's Hospital at Montefiore, Albert Einstein College of Medicine
The Bronx, New York, 10467
Marina Reznik, MD, MS, 718-741-2494, mreznik@montefiore.org
About this study
Official title: Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.
Read the detailed description
The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components.
Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.
- Conditions
- Asthma in Children
- Being tested
- PRAGMATIC-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRAGMATIC-SBehavioural
Intervention combines EHR-based guideline prompts, electronic MAF submission, school-based directly observed therapy (DOT), and Asthma Outreach Workers (AOWs) providing care coordination, adherence support, and communication between families, schools, and providers.
| Study group | Role | What they receive |
|---|---|---|
| PRAGMATIC-S | Experimental | Primary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support. Receives: Behavioral: PRAGMATIC-S |
| Enhanced Usual Care | No intervention | Standard of care EHR clinician prompts for guideline-based asthma care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control - continuous
Asthma control will be measured using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0 ("Everyday") to 5 ("Not at all"), yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.
Asthma control will be analyzed as a continuous variable.
Measured: Baseline, 4 months, 8 months, and 12 months
Secondary outcomes (3)
Pediatric Asthma Caregiver's Quality of Life
The caregiver's quality of life will be assessed using the validated Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ; also referred to as Juniper's Asthma Quality of Life Questionnaire). This questionnaire consists of 13 items which evaluate the impact of the child's asthma on the caregiver's quality of life. Responses to each item are rated on a 7-point scale ranging from 1-7, wherein 1 means "all of the time" or "very, very worried/concerned," and 7 means "none of the time" or "not worried/concerned," yielding an overall possible scoring range of 7-91, such that higher scores are indicative of less asthma related quality of life impairment.
Measured: Baseline, 4 months, 8 months, and 12 months
Percent of participants with 1 or more guideline-based corrective actions taken
Percent of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR), will be summarized by study arm.
Measured: Up to 24 months (following intervention)
Asthma Control - dichotomous
Asthma control will also be measured as a dichotomous variable using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.
Asthma control will be analyzed as dichotomous variable with a score of 19 or less indicating uncontrolled asthma.
Measured: Baseline, 4 months, 8 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start12 Feb 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized design. Prior to participant enrollment, each practice will be matched into 9 pairs based on size of the practice and provider type. Practices will then be randomly selected within each pair to receive PRAGMATIC-S or remain as an Enhanced Usual Care (eUC) site. Practices will join study in 5 waves (2-4 practices per wave).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marina Reznik, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224061
- Sponsor's protocol ID
- 2025-17054
- Other IDs
- R01HL181061, 2025
- Acronym
- PRAGMATIC-S
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to the research data, study protocols, data collection instruments, codebooks that contain variable names and format codes will be provided. Quantitative datasets will be in SPSS, STATA and/or SAS formats. All datasets that are shared will be accompanied by the relevant metadata. Scientific data will require either SAS, STATA or SPSS statistical software for manipulation. No other specialized tools will be needed to access or manipulate shared scientific data to support replication or reuse. To facilitate efficient use, all data and materials will be structured and described using the following standards: The majority of the longitudinal surveys use validated, standardized instruments. The SAS, STATA or SPSS codes used to score the measures and to prepare raw data for analyses will be provided. Medical record, hospitalization and ED data, electronic adherence monitor and data for all other measures will be organized and described according to best practices.
Publications
Walters S, Wilson L, Konty K, Day S, Agerton T, Olson C. Disparities among children with asthma in New York City. Epi Data Brief (126); September 2021.
Black LI, Benson V. Tables of Summary Health Statistics for U.S. Children: 2018 National Health Interview Survey.
Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12.
PubMed 24336438Frey SM, Fagnano M, Halterman JS. Caregiver education to promote appropriate use of preventive asthma medications: what is happening in primary care? J Asthma. 2016;53(2):213-9. doi: 10.3109/02770903.2015.1075549. Epub 2015 Aug 18.
PubMed 26288255Halterman JS, Auinger P, Conn KM, Lynch K, Yoos HL, Szilagyi PG. Inadequate therapy and poor symptom control among children with asthma: findings from a multistate sample. Ambul Pediatr. 2007 Mar-Apr;7(2):153-9. doi: 10.1016/j.ambp.2006.11.007.
PubMed 17368410Okelo SO, Siberry GK, Solomon BS, Bilderback AL, Yamazaki M, Hetzler T, Ferrell CL, Dhepyasuwan N, Serwint JR; CORNET Investigators. Asthma treatment decisions by pediatric residents do not consistently conform to guidelines or improve with level of training. Acad Pediatr. 2014 May-Jun;14(3):287-93. doi: 10.1016/j.acap.2013.12.008. Epub 2014 Mar 12.
PubMed 24629404National Heart Lung and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. NIH Publication Number 08-5846. Bethesda, MD: 2007.
Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
PubMed 17353040Schatz M, Zeiger RS, Drane A, Harden K, Cibildak A, Oosterman JE, Kosinski M. Reliability and predictive validity of the Asthma Control Test administered by telephone calls using speech recognition technology. J Allergy Clin Immunol. 2007 Feb;119(2):336-43. doi: 10.1016/j.jaci.2006.08.042. Epub 2006 Dec 27.
PubMed 17194469Halterman JS, Borrelli B, Fisher S, Szilagyi P, Yoos L. Improving care for urban children with asthma: design and methods of the School-Based Asthma Therapy (SBAT) trial. J Asthma. 2008 May;45(4):279-86. doi: 10.1080/02770900701854908.
PubMed 18446591Halterman JS, Szilagyi PG, Fisher SG, Fagnano M, Tremblay P, Conn KM, Wang H, Borrelli B. Randomized controlled trial to improve care for urban children with asthma: results of the School-Based Asthma Therapy trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):262-8. doi: 10.1001/archpediatrics.2011.1.
PubMed 21383275Halterman JS, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Sauer J, Butz A. The school-based preventive asthma care trial: results of a pilot study. J Pediatr. 2012 Dec;161(6):1109-15. doi: 10.1016/j.jpeds.2012.05.059. Epub 2012 Jul 10.
PubMed 22785264Halterman JS, Fagnano M, Tajon RS, Tremblay P, Wang H, Butz A, Perry TT, McConnochie KM. Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. JAMA Pediatr. 2018 Mar 5;172(3):e174938. doi: 10.1001/jamapediatrics.2017.4938. Epub 2018 Mar 5.
PubMed 29309483Halterman JS, Riekert KA, Fagnano M, Tremblay PJ, Blaakman SW, Tajon R, Wang H, Borrelli B. Effect of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity: a 3-arm randomized controlled trial. J Asthma. 2022 Mar;59(3):494-506. doi: 10.1080/02770903.2020.1856869. Epub 2021 Jan 8.
PubMed 33307900Cain A, Reznik M. The Principal and Nurse Perspective on Gaps in Asthma Care and Barriers to Physical Activity in New York City Schools: A Qualitative Study. Health Educ Behav. 2018 Jun;45(3):410-422. doi: 10.1177/1090198117736351. Epub 2017 Oct 31.
PubMed 29084455
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
- ClinicalTrials.gov ID
- NCT07224061
- Acronym / sponsor ID
- PRAGMATIC-S / 2025-17054
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 3 Nov 2025 (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.
The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.
Detailed description
The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components.
Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized design. Prior to participant enrollment, each practice will be matched into 9 pairs based on size of the practice and provider type. Practices will then be randomly selected within each pair to receive PRAGMATIC-S or remain as an Enhanced Usual Care (eUC) site. Practices will join study in 5 waves (2-4 practices per wave).
| Arm | Type | Receives |
|---|---|---|
| PRAGMATIC-S | Experimental | Behavioral: PRAGMATIC-SPrimary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support. |
| Enhanced Usual Care | No intervention | –Standard of care EHR clinician prompts for guideline-based asthma care |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Physician-diagnosed asthma documented in EHR
- Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, >2 days/week with symptoms, >2 days/week using rescue medication, >2 days/month with nighttime symptoms, or >2 episodes/year that required systemic corticosteroids
- Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers)
- Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
- Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected.
Key exclusion criteria (5 listed)
- Family plans to leave school or city within 6 months
- Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease)
- Children in foster care or other situations in which consent cannot be obtained from a legal guardian
- Participation in concurrent asthma intervention study
- Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire
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 |
|---|---|---|
| PRAGMATIC-SIntervention combines EHR-based guideline prompts, electronic MAF submission, school-based directly observed therapy (DOT), and Asthma Outreach Workers (AOWs) providing care coordination, adherence support, and communication between families, schools, and providers. | Behavioural | PRAGMATIC-S |
Primary outcome
Asthma Control - continuous
Time frame: Baseline, 4 months, 8 months, and 12 months
Asthma control will be measured using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0 ("Everyday") to 5 ("Not at all"), yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control. Asthma control will be analyzed as a continuous variable.
3 secondary outcomes
Pediatric Asthma Caregiver's Quality of Life
Time frame: Baseline, 4 months, 8 months, and 12 months
Percent of participants with 1 or more guideline-based corrective actions taken
Time frame: Up to 24 months (following intervention)
Asthma Control - dichotomous
Time frame: Baseline, 4 months, 8 months, and 12 months
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 29 Apr 2026.
- BackgroundWalters S, Wilson L, Konty K, Day S, Agerton T, Olson C. Disparities among children with asthma in New York City. Epi Data Brief (126); September 2021.
- BackgroundBlack LI, Benson V. Tables of Summary Health Statistics for U.S. Children: 2018 National Health Interview Survey.
- Background: PubMed 24336438Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12.
- Background: PubMed 26288255Frey SM, Fagnano M, Halterman JS. Caregiver education to promote appropriate use of preventive asthma medications: what is happening in primary care? J Asthma. 2016;53(2):213-9. doi: 10.3109/02770903.2015.1075549. Epub 2015 Aug 18.
- Background: PubMed 17368410Halterman JS, Auinger P, Conn KM, Lynch K, Yoos HL, Szilagyi PG. Inadequate therapy and poor symptom control among children with asthma: findings from a multistate sample. Ambul Pediatr. 2007 Mar-Apr;7(2):153-9. doi: 10.1016/j.ambp.2006.11.007.
- Background: PubMed 24629404Okelo SO, Siberry GK, Solomon BS, Bilderback AL, Yamazaki M, Hetzler T, Ferrell CL, Dhepyasuwan N, Serwint JR; CORNET Investigators. Asthma treatment decisions by pediatric residents do not consistently conform to guidelines or improve with level of training. Acad Pediatr. 2014 May-Jun;14(3):287-93. doi: 10.1016/j.acap.2013.12.008. Epub 2014 Mar 12.
- BackgroundNational Heart Lung and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. NIH Publication Number 08-5846. Bethesda, MD: 2007.
- Background: PubMed 17353040Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
- Background: PubMed 17194469Schatz M, Zeiger RS, Drane A, Harden K, Cibildak A, Oosterman JE, Kosinski M. Reliability and predictive validity of the Asthma Control Test administered by telephone calls using speech recognition technology. J Allergy Clin Immunol. 2007 Feb;119(2):336-43. doi: 10.1016/j.jaci.2006.08.042. Epub 2006 Dec 27.
- Background: PubMed 18446591Halterman JS, Borrelli B, Fisher S, Szilagyi P, Yoos L. Improving care for urban children with asthma: design and methods of the School-Based Asthma Therapy (SBAT) trial. J Asthma. 2008 May;45(4):279-86. doi: 10.1080/02770900701854908.
- Background: PubMed 21383275Halterman JS, Szilagyi PG, Fisher SG, Fagnano M, Tremblay P, Conn KM, Wang H, Borrelli B. Randomized controlled trial to improve care for urban children with asthma: results of the School-Based Asthma Therapy trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):262-8. doi: 10.1001/archpediatrics.2011.1.
- Background: PubMed 22785264Halterman JS, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Sauer J, Butz A. The school-based preventive asthma care trial: results of a pilot study. J Pediatr. 2012 Dec;161(6):1109-15. doi: 10.1016/j.jpeds.2012.05.059. Epub 2012 Jul 10.
- Individual participant dataSharing planned: Yes. In addition to the research data, study protocols, data collection instruments, codebooks that contain variable names and format codes will be provided. Quantitative datasets will be in SPSS, STATA and/or SAS formats. All datasets that are shared will be accompanied by the relevant metadata. Scientific data will require either SAS, STATA or SPSS statistical software for manipulation. No other specialized tools will be needed to access or manipulate shared scientific data to support replication or reuse. To facilitate efficient use, all data and materials will be structured and described using the following standards: The majority of the longitudinal surveys use validated, standardized instruments. The SAS, STATA or SPSS codes used to score the measures and to prepare raw data for analyses will be provided. Medical record, hospitalization and ED data, electronic adherence monitor and data for all other measures will be organized and described according to best practices.
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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.
Marina Reznik, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRAGMATIC-S in people with Asthma in Children, run by Montefiore Medical Center 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 6 inclusion and 5 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 29 Apr 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 Marina Reznik, MD, MS (718-741-2494, mreznik@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control - continuous (time frame: Baseline, 4 months, 8 months, and 12 months). 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 NCT07224061, which also lists 58 linked publications.
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 29 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.