The Patient-Centered Outcomes Research Institute (PCORI) has approved an award for the American Academy of Family Physicians (AAFP) of $31 million to fund a large comparative study of asthma treatments.
The Patient-Centered Outcomes Research Institute (PCORI) has approved an award for the American Academy of Family Physicians (AAFP) of $31 million to fund a large comparative study of asthma treatments. Penn State College of Medicine will partner with the AAFP, serving as the data coordinating center for the study.
The Individualizing Treatment for Asthma in Primary Care (iTREAT-PC) study will enroll 3,200 adults and adolescents 12 to under 76 years of age who have asthma. The study will be conducted at 10 AAFP National Research Network (NRN) sites across the United States. The aim of iTREAT-PC is to determine whether inhaled corticosteroids, long-term antibiotic treatment, or both work best in specific patient groups.
Current asthma treatment guidelines recommend the use of inhaled corticosteroids as rescue therapy, specifically as single maintenance and reliever therapy (SMART). Long-term use of the macrolide antibiotic azithromycin has been as effective as SMART in reducing asthma exacerbations. However, it is not clear how specific individuals respond to each treatment nor how the two work together. iTREAT-PC will be the first clinical study to compare these therapies.
The study will have four treatment arms: SMART treatment, azithromycin treatment, SMART plus azithromycin treatment, and control. Participants coming from primary care practices across the U.S. will be monitored for 16 months, comparing yearly asthma exacerbation rates across all treatment arms. Secondary outcomes will be asthma control and asthma quality of life.
To better understand the impact of asthma variations on treatment response, the researchers will also analyze variations, such as smoking status, health literacy, the onset of asthma associated with a lower respiratory tract infection, total blood eosinophil counts, biomarkers for Mycoplasma pneumoniae and Chlamydia pneumoniae, and Black/African American race.
Results from this study are intended to be used by physicians and patients to help determine individualized treatments for patients based on specific characteristics.
“Nearly all family physicians encounter patients with asthma, and we know that some patient groups face higher rates of death and high rates of severe complications,” commented Julie Wood, MD, MPH, FAAFP, senior vice president of research, science, and health of the public at the AAFP. “By further understanding which types of treatments are more or less effective for different patients, we can treat patients with asthma more effectively and help improve their quality of life.”
A feasibility study will begin in 2023, and the full study is expected to start in July 2024.