Individualizing Treatment for Asthma in Primary Care

Summary

This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system.

Conditions

• Asthma
• Bronchial Diseases
• Respiratory Tract Infections
• Lung Diseases, Obstructive
• Lung Diseases
• Respiratory Hypersensitivity
• Immune System Diseases

Interventions

OTHER

Asthma Symptom Monitoring online tools

All participants will be provided access to the Asthma Symptom Monitoring tools and 3/4's will be randomized to one of the other three arms above

DRUG

Inhaled Steroids

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 Pill

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

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

• Rutgers University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Reliant Medical Group

  collaborator OTHER

• Kelsey Research Foundation

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• DARTNet Institute

  lead OTHER_GOV

Principal Investigators

• Wilson D Pace, MD · DARTNet Institute

• David T Mauger, PhD · Penn State University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2024-09-30

Completion

2024-12-31

FDA Drug

Yes

Countries

• United States

Study Locations