Actively Recruiting
Individualizing Treatment for Asthma in Primary Care (Full Study)
Led by DARTNet Institute · Updated on 2025-10-29
3200
Participants Needed
13
Research Sites
223 weeks
Total Duration
On this page
Sponsors
D
DARTNet Institute
Lead Sponsor
P
Penn State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Individualizing Treatment for Asthma in Primary Care (Full Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical asthma diagnosis for at least 1 year
- Age between 13 and 75 years
- Prescription for inhaled corticosteroids used regularly or as needed for controller therapy
- Current Asthma Control Test (ACT) score below 20 OR asthma exacerbation requiring 72+ hours of systemic steroids or hospitalization of at least 24 hours between 30 and 365 days before enrollment
- Able to provide consent or assent in English or Spanish
- Patients with COPD may participate if never smokers without secondary lung disease causing airway obstruction, or current/former smokers with obstruction but normal lung diffusing capacity in past 24 months
- Patients on medications that may interact with azithromycin can enroll if they agree to cardiac rhythm monitoring before and during treatment
You will not qualify if you...
- Another family member living in the same household already enrolled in the study
- Life expectancy less than 1 year
- No prescription for inhaled corticosteroids
- Active treatment for hematologic or solid organ cancer except basal or squamous cell skin cancer unless more than 12 months from original therapy
- Allergy to macrolides or conditions making macrolide use risky (e.g., liver disease, end-stage kidney disease, certain heart conditions)
- Use of daily or every other day oral steroids
- Asthma exacerbation treated with systemic steroids or hospitalization within the past month
- Currently using Rescue ICS or antibiotic therapy expected to last more than 30 days
- Use of medications with known risk of prolonged QT interval associated with torsades de pointes
- Use of medications requiring close monitoring with macrolides such as digoxin, warfarin, theophylline, ergotamine, cyclosporine, hexobarbital, phenytoin, or nelfinavir
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
DARTNet Institute
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University Colorado-Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
AdventHealth
Orlando, Florida, United States, 32803
Not Yet Recruiting
4
University of Kansas
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
5
Reliant Medical Group
Worcester, Massachusetts, United States, 01608
Actively Recruiting
6
University of Missouri
Columbia, Missouri, United States, 65211
Not Yet Recruiting
7
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
8
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
9
University North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Atrium Health
Charlotte, North Carolina, United States, 28207
Actively Recruiting
11
JPS Health Network
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
12
Kelsey Research Foundation
Houston, Texas, United States, 77005
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98105
Not Yet Recruiting
Research Team
B
Brian K Manning, MPH
CONTACT
J
Joel Shields, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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