NCT07052942

Individualizing Treatment for Asthma in Primary Care (Full Study)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,200 (estimated)
• Sponsor: DARTNet Institute · Other Government
• Sex: All
• Age: 13 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Design. Four arm, patient level randomized trial (N=3200). Comparators: Rescue inhaled corticosteroids (R-ICS) versus azithromycin versus R-ICS plus azithromycin versus control patients. All arms will include home monitoring of asthma symptoms using various web application approaches. R-ICS therapy will consist of a corticosteriod/formoterol inhaler, a stand-alone ICS inhaler used with usual rescue therapy or when available a combination corticosteroid/albuterol inhaler, the initial azithromycin dose will be 500mg (10mg/Kg) three times a week and may be titrated down to 250mg (10mg/Kg) three times per week for side effects. Exacerbations will be blindly adjudicated. Individuals who experience three exacerbations in \< 12 months will have their treatments "stepped-up,"unless in the dual treatment arm; control participants going to R-ICS and single therapy participants to dual therapy. Individuals completing either of the azithromycin arms will be offered up to 12 additional months of follow-up after stopping the azithromycin only.

Conditions

• Asthma
• Asthma Attack
• Asthma Exacerbations

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-08-01
• Primary completion: 2029-11-15
• Completion: 2029-11-15
• First posted: 2025-07-08
• Last updated: 2025-10-29

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study