Individualizing Treatment for Asthma in Primary Care (Full Study)

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.

Conditions

• Asthma
• Asthma Attack
• Asthma Exacerbations

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).

Sponsors & Collaborators

• Penn State University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• RAND

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Reliant Medical Group

  collaborator OTHER

• Kelsey Research Foundation

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• University of Missouri-Columbia

  collaborator OTHER

• John Peter Smith Health Network

  collaborator UNKNOWN

• Rutgers University

  collaborator OTHER

• AdventHealth

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• DARTNet Institute

  lead OTHER_GOV

Principal Investigators

• Wilson D Pace, MD, FAAFP · DARTNet Institute

• Dave Mauger, PhD · Penn State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2029-11-15

Completion

2029-11-15

FDA Drug

Yes

Countries

• United States

Study Locations