Individualizing Treatment for Asthma in Primary Care (Full Study)

Conditions

• Asthma
• Asthma Attack
• Asthma Exacerbations

Eligibility Criteria

Sex

ALL

Age

13 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Inhaled corticosteroid (ICS) — DRUG
  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.
• Azithromycin — DRUG
  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.
• Asthma Symptom Monitoring Web-based Application — OTHER
  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).

Study Details

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.

Key Dates

Start date

Aug 1, 2025

Status verified

Oct 2025

Primary completion

Nov 15, 2029

Completion

Nov 15, 2029

Study Design

Enrollment

3,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Rate of Asthma Exacerbations Per Year [ Time Frame: Follow-up is up to 16 months. ]

Central Contacts

• Brian K Manning, MPH
  1-866-297-8521
  [email protected]
• Joel Shields, MA
  1-866-297-8521

Locations (13)

Find similar trials in Aurora, CO

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