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Individualizing Treatment for Asthma in Primary Care (Full Study)
Sponsor: DARTNet Institute
Summary
While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.
Key Details
Gender
All
Age Range
13 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
3200
Start Date
2025-08-01
Completion Date
2029-11-15
Last Updated
2025-10-29
Healthy Volunteers
No
Conditions
Interventions
Inhaled corticosteroid (ICS)
Participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid (beclomethasone, budesonide, fluticasone, mometasone, ciclesodine) of their choice with their current reliever therapy or be converted to budesonide/albuterol as rescue therapy.
Azithromycin
Participants will take 500mg of azithromycin three times a week or 10mg/kg if under 50Kg which may be reduced to 250mg/Kg for side effects.
Asthma Symptom Monitoring Web-based Application
All participants will be provided access to the Asthma Symptom Monitoring (ASM) tools. ASM can be integrated with electronic health records (EHR) or used as a stand alone application. Participants will answer 5 questions about their asthma each week. If symptoms are problematic, participants can request a call back from a person on their care team. Participants can view a graph of their data, watch videos, and record peak flows. Clinicians and members of the care team can view data in the EHR (not for stand alone web app).
Locations (13)
DARTNet Institute
Aurora, Colorado, United States
University Colorado-Denver
Aurora, Colorado, United States
AdventHealth
Orlando, Florida, United States
University of Kansas
Kansas City, Kansas, United States
Reliant Medical Group
Worcester, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Mt. Sinai School of Medicine
New York, New York, United States
University North Carolina
Chapel Hill, North Carolina, United States
Atrium Health
Charlotte, North Carolina, United States
JPS Health Network
Fort Worth, Texas, United States
Kelsey Research Foundation
Houston, Texas, United States
University of Washington
Seattle, Washington, United States