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RECRUITING
NCT07052942
PHASE4

Individualizing Treatment for Asthma in Primary Care (Full Study)

Sponsor: DARTNet Institute

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

OTHER

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