Individualizing Treatment for Asthma in Primary Care (Full Study)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 75
Healthy Volunteers: f
View:

• A clinical asthma diagnosis for at least 1 year;

• 13-75 years of age;

• A prescription for an ICS either used regularly, or on an as needed controller, not reliever, schedule - ICS or ICS + LABA or ICS+LABA+LAMA;

• A current ACT total score of \<20 OR an exacerbation requiring 72 hours or more of systemic steroids or a hospitalization of at least 24 hours \> 30 days and \< 365 days prior to enrollment;

• Able to provide consent (adolescents: assent) in English or Spanish; (i.e., cognitively impaired individuals are deemed not to be able to provide consent and thus do not meet inclusion criteria.);

• Patients with a coexisting clinical diagnosis of COPD are eligible if they meet any one of the following criteria:

• (i) Never smoker without secondary lung disease causing airway obstruction. (ii) Current or former smoker with obstruction on PFTs, but normal diffusing capacity of the lungs for carbon monoxide (DLCO) in the past 24 months.

• Patients on medications that may interact with azithromycin but are not totally excluded may be enrolled if they agree to a cardiac rhythm strip after consent and prior to randomization (or have an ECG within the prior 24 months as a baseline assessment) and a repeat rhythm strip after one week if randomized to one of the azithromycin arms of the study.

Locations
United States
Colorado
DARTNet Institute
RECRUITING
Aurora
University Colorado-Denver
RECRUITING
Aurora
Florida
AdventHealth
NOT_YET_RECRUITING
Orlando
Kansas
University of Kansas
NOT_YET_RECRUITING
Kansas City
Massachusetts
Reliant Medical Group
RECRUITING
Worcester
Missouri
University of Missouri
NOT_YET_RECRUITING
Columbia
North Carolina
University North Carolina
RECRUITING
Chapel Hill
Atrium Health
RECRUITING
Charlotte
New Jersey
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
Mt. Sinai School of Medicine
RECRUITING
New York
Texas
JPS Health Network
NOT_YET_RECRUITING
Fort Worth
Kelsey Research Foundation
RECRUITING
Houston
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Contact Information
Primary
Brian K Manning, MPH
Brian.manning@dartnet.info
1-866-297-8521
Backup
Joel Shields, MA
1-866-297-8521
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2029-11-15
Participants
Target number of participants: 3200
Treatments
Active_comparator: Inhaled corticosteroids as part of rescue therapy (R-ICS)
Maintenance And Reliever Therapy (MART), or Patient Activated Reliever Triggered Inhaled Corticosteroids (PARTICS) - this includes budesonide-albuterol (AirSupra)
Active_comparator: Azithromycin (AZ)
Azithromycin - 500mg three times per week. Can be reduced to 250 mg three times per week for side effects.
Other: Enhanced Usual Care
Participants will be asked to use an online Asthma Symptom Monitoring (ASM) tool to enhance communication with the medical team as well as self-awareness of their asthma symptoms. There are no study drugs in this intervention.
Active_comparator: Inhaled corticosteroids as part of rescue therapy (R-ICS) + Azithromycin
R-ICS either as MART therapy or PARTICS + Azithromycin
Related Therapeutic Areas
Sponsors
Collaborators: Icahn School of Medicine at Mount Sinai, John Peter Smith Health Network, University of Kansas, RAND, Kelsey Research Foundation, University of Washington, University of North Carolina, Reliant Medical Group, Wake Forest University Health Sciences, AdventHealth, University of Missouri-Columbia, Rutgers University, Penn State University, University of Colorado, Denver
Leads: DARTNet Institute

This content was sourced from clinicaltrials.gov