Aligning With Schools To Help Manage Asthma (Project ASTHMA)

NCT03032744 | Completed Results

• 2 other identifiers: IMPACT1UL1TR001412
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 children from communities with health disparities.

Conditions

Asthma

Keywords

Pediatric; School Based Health Center

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 1-month, 3-month, 5-month, 7-month

Secondary Outcomes (2)

• Change in ACT Score From Baseline to 7-month Follow-up

  Baseline, 1-month, 3-month, 5-month, 7-month

• Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up

  Baseline, 1-month, 3-month, 5-month, 7-month

Study Arms (2)

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.

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.

Other: Asthma Assessment & Management; Other: Asthma Education

Interventions

Asthma Assessment & Management OTHER

Asthma Assessment \& Management based on NAEPP-EPR3 guidelines

Intervention; Usual Care

Asthma Education OTHER

Asthma education on medications

Intervention; Usual Care

Controller medication at school OTHER

Students will receive the morning dose of their daily preventive asthma medication at school on school days.

Intervention

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Underlying heart or lung disease other than asthma
• Student has well controlled asthma

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• 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.

  PMID: 33322963 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Lucy C Holmes, MD, MPH
• Organization: University at Buffalo

LHolmes@upa.chob.edu

7163230034

Study Officials

• Lucy C Holmes, MD, MPH

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: January 17, 2017
• Primary Completion: July 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)