Comparing Four Ways to Decrease Asthma Attacks among Patients with Asthma -- The iTREAT-PC Study

Project Summary

PCORI has identified the need for large, high-impact studies that address critical decisions faced by patients, families, caregivers, clinicians, and the health and healthcare community. In 2020, PCORI launched the Phased Large Awards for Comparative Effectiveness Research initiative to support comparative effectiveness studies that focus on select goals from PCORI's National Priorities for Health. PCORI funds these projects in two parts. The first part examines if a full study is feasible. Depending on the results of the first part, some projects may also have a second part to conduct the full study.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Asthma is a health problem that can make it hard to breathe. Symptoms include shortness of breath, tightness in the chest, coughing, and wheezing. People may miss school or work or need to go to the hospital when they have an asthma attack.

Using an inhaler with a medicine called an inhaled corticosteroid, or ICS, every day can help reduce asthma attacks. Another way to reduce attacks is with a medicine called azithromycin. This medicine can reduce asthma attacks when used for more than six months.

In this study, the research team is comparing four ways to reduce asthma attacks. The first way is enhanced usual care alone, which consists of routine asthma treatment plus an app to check and record asthma symptoms at home. The second way is enhanced usual care plus ICS. The third way is enhanced usual care plus azithromycin. The fourth way is enhanced usual care plus ICS and azithromycin.

Who can this research help?

Results may help patients with asthma and their doctors when considering ways to reduce asthma attacks.

What is the research team doing?

The research team is enrolling 3,200 patients with asthma from 250 primary care clinics across the United States. The team is assigning patients by chance to receive one of the four ways to reduce asthma attacks for 16 months. Patients taking azithromycin take it three times a week. Clinicians, like doctors or nurses, can lower the dosage if patients have negative side effects.

At the start of the study and every 2 months for 16 months, the research team is measuring the number of severe asthma attacks. The team is also surveying patients about:

• Asthma control
• Quality of life
• The number of days patients missed work or school or couldn't do their usual activities due to asthma

Patients with asthma, caregivers, patient advocacy groups, and health insurers are helping to plan and conduct this study.

Research methods at a glance

Design ElementDescriptionDesignRandomized controlled trialPopulation3,200 patients ages 13–75 with moderate to severe asthma from 250 clinics across the United StatesInterventions/ComparatorsEnhanced usual care aloneEnhanced usual care plus ICSEnhanced usual care plus azithromycinEnhanced usual care plus ICS and azithromycinOutcomesPrimary: rate of severe asthma attacks per year, defined as the number of asthma attacks, emergency room visits, or hospitalizations requiring corticosteroidsSecondary: asthma control, asthma quality of life, and number of days lost from work or school or days not able to carry out usual activities due to asthmaTimeframe More InformationTimeframe Length of follow-up for collecting data on primary outcomes. View GlossaryClose 16-month follow-up for study outcomes