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Completed

NCT Number: NCT03032744

Aligning With Schools To Help Manage Asthma (Project 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.

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Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Asthma Assessment & Management

Other

Asthma Assessment & Management based on NAEPP-EPR3 guidelines

Asthma Education

Other

Asthma education on medications

Controller medication at school

Other

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

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

    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

Secondary outcomes

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

    Time frame: Baseline, 1-month, 3-month, 5-month, 7-month

    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

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

    Time frame: Baseline, 1-month, 3-month, 5-month, 7-month

    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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Aligning With Schools To Help Manage Asthma

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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