Actively Recruiting

Phase 4
Age: 13Years - 75Years
All Genders
ID07052942

Individualizing Treatment for Asthma in Primary Care: Comparing Rescue Inhaled Corticosteroids and Azithromycin in a Randomized Trial

Led by DARTNet Institute · Updated on 2025-10-29

3200

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

Sponsors

D

DARTNet Institute

Lead Sponsor

P

Penn State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying different ways to reduce asthma exacerbations in primary care patients who have persistent asthma. This study compares two treatment approaches: using inhaled corticosteroids (ICS) as rescue therapy, known as MART or PARTICS therapy, and using the antibiotic azithromycin as a preventive treatment. The study aims to find the best way to tailor asthma treatment to individual patient needs while monitoring for long-term side effects of ICS use. The study randomly assigns 3200 participants into four groups: one using rescue inhaled corticosteroids (R-ICS) alone, one using azithromycin alone, one using both R-ICS and azithromycin, and a control group receiving enhanced usual care. R-ICS treatment includes corticosteroid/formoterol inhalers or stand-alone ICS inhalers combined with usual rescue therapy. Azithromycin is given three times a week, starting at 500mg and possibly reduced to 250mg if side effects occur. All participants use a web-based Asthma Symptom Monitoring tool to track symptoms and communicate with their care team. Participants will be followed for up to 16 months to measure the rate of asthma exacerbations per year and assess asthma control, quality of life, and days lost from work or school due to asthma. The study collects symptom data weekly through the monitoring app, and exacerbations are reviewed blindly. Those experiencing frequent exacerbations may have their treatment adjusted. Participants completing azithromycin treatment may be followed for an additional 12 months after stopping the drug to monitor outcomes and safety.

CONDITIONS

Brief Title

Individualizing Treatment for Asthma in Primary Care (Full Study)

Who Can Participate

Age: 13Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A clinical asthma diagnosis for at least 1 year
  • Aged 13 to 75 years
  • Prescription for an inhaled corticosteroid (ICS) used regularly or on an as-needed controller schedule
  • Asthma Control Test (ACT) score below 20 OR an asthma exacerbation requiring 72 hours or more of systemic steroids or hospitalization between 30 and 365 days before enrollment
  • Able to provide consent or assent in English or Spanish
  • Patients with coexisting COPD who meet specific lung function criteria
  • Patients on medications that may interact with azithromycin may enroll with required cardiac monitoring
Not Eligible

You will not qualify if you...

  • Another family member living in the same household already enrolled
  • Life expectancy less than 1 year
  • No prescription for inhaled corticosteroids
  • Active treatment for cancer other than certain skin cancers within the past year
  • Allergy or conditions making macrolide antibiotics unsafe, including specific liver, kidney, heart, or electrolyte problems
  • Use of daily or every other day oral steroids
  • Systemic steroid treatment or hospitalization for asthma exacerbation within the past month
  • Current use of rescue inhaled corticosteroids or antibiotics expected to last more than 30 days
  • Use of medications with known risk of prolonged QT interval contraindicated with azithromycin
  • Use of specified medications requiring close monitoring when combined with macrolides

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 16 months

Participants receive one of the following interventions: inhaled corticosteroids as rescue therapy, azithromycin, both inhaled corticosteroids and azithromycin, or enhanced usual care. All participants will use an online Asthma Symptom Monitoring tool weekly to track symptoms and communicate with their care team.

Weekly symptom monitoring with web application; visits and assessments as scheduled by the care team

Follow-up

Duration - Up to 12 months after treatment ends

Participants who complete the azithromycin treatment arms may be offered up to 12 additional months of follow-up after stopping azithromycin to monitor asthma control and quality of life.

Periodic follow-up visits depending on treatment arm

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

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Research Team

B

Brian K Manning, MPH

J

Joel Shields, MA

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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