Individualizing Treatment for Asthma in Primary Care (Full Study)
Start Date
8/1/2025
Completion Date
11/15/2029
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.
Detailed Description
Design. Four arm, patient level randomized trial (N=3200). Comparators: Rescue inhaled corticosteroids (R-ICS) versus azithromycin versus R-ICS plus azithromycin versus control patients. All arms will include home monitoring of asthma symptoms using various web application approaches. R-ICS therapy will consist of a corticosteriod/formoterol inhaler, a stand-alone ICS inhaler used with usual rescue therapy or when available a combination corticosteroid/albuterol inhaler, the initial azithromycin dose will be 500mg (10mg/Kg) three times a week and may be titrated down to 250mg (10mg/Kg) three times per week for side effects. Exacerbations will be blindly adjudicated. Individuals who experience three exacerbations in \< 12 months will have their treatments "stepped-up,"unless in the dual treatment arm; control participants going to R-ICS and single therapy participants to dual therapy. Individuals completing either of the azithromycin arms will be offered up to 12 additional months of follow-up after stopping the azithromycin only.
Eligibility Criteria
Age Range: 13 years to 75 years
Interventions
Inhaled corticosteroid (ICS)
Azithromycin
Asthma Symptom Monitoring Web-based Application
Conditions
Locations
DARTNet Institute
Aurora, Colorado 80045
United States
University Colorado-Denver
Aurora, Colorado 80045
United States
AdventHealth
Orlando, Florida 32803
United States
University of Kansas
Kansas City, Kansas 66160
United States
Reliant Medical Group
Worcester, Massachusetts 01608
United States
University of Missouri
Columbia, Missouri 65211
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United States
Mt. Sinai School of Medicine
New York, New York 10029
United States
University North Carolina
Chapel Hill, North Carolina 27599
United States
Atrium Health
Charlotte, North Carolina 28207
United States
JPS Health Network
Fort Worth, Texas 76104
United States
Kelsey Research Foundation
Houston, Texas 77005
United States
University of Washington
Seattle, Washington 98105
United States