American Academy of Family Physicians awards $31 million for comparative asthma treatment study
The Patient-Centered Outcomes Research Institute (PCORI) has approved a $31 million award to the American Academy of Family Physicians (AAFP) for a large comparative study of asthma treatments.
The Patient-Centered Outcomes Research Institute (PCORI) has approved a $31 million award to the American Academy of Family Physicians (AAFP) for a large comparative study of asthma treatments. Penn State College of Medicine will partner with the AAFP, which will serve as the data coordinating center for the study.
The Individualized Treatment for Asthma in Primary Care (iTREAT-PC) study will enroll 3,200 adults and adolescents aged 12 to 76 years who have asthma. The study will be conducted at 10 AAFP National Research Network (NRN) sites across the United States. The purpose 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, particularly 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 treatments.
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 US would be monitored for 16 months, comparing annual asthma intensity across all treatment arms. Secondary outcomes would be asthma control and asthma quality of life.
To better understand the impact of asthma variations on treatment response, the researchers will also analyze changes such as smoking status, health literacy, asthma onset associated with lower respiratory tract infections, total blood eosinophil count, biomarkers, and more. mycoplasma pneumoniae And chlamydia pneumoniaand Black/African American race.
The results of this study are intended to help clinicians and patients determine individualized treatment for patients based on specific characteristics.
“Almost all family physicians deal with asthma patients, and we know that certain patient groups face higher rates of death and higher rates of serious complications,” says Julie Wood, MD, MPH, FAAFP, Research, The senior vice president for science and health commented. of the public in the AAFP. “By further understanding what types of treatments are more or less effective for different patients, we can treat asthma patients more effectively and help improve their quality of life.”
A feasibility study will begin in 2023, and the full study is expected to begin in July 2024.