Penn State lends statistical expertise to nearly $31 million asthma clinical trial

Asthma, which causes inflammation of the lungs and difficulty breathing, affects more than 20 million people in the U.S., according to the Asthma and Allergy Foundation of America. To better understand personalized treatment options, Penn State College of Medicine, in conjunction with the American Academy of Family Physicians and DARTNet Institute, will receive nearly $31 million from the Patient-Centered Outcomes Research Institute (PCORI) to conduct a large-scale, comparative study on asthma therapies for patients 12 and older. Penn State will serve as the data coordinating center for the study, which will examine individualized treatment for asthma in primary care (iTREAT-PC).

Current asthma treatments — inhaled corticosteroids, as part of rescue therapy, and long-term antibiotic use — have both been shown to improve asthma symptoms. However, it is unclear which treatment option is most beneficial for certain individuals and whether these therapies work better alone or together. The iTREAT-PC study will compare these options and examine multiple markers related to asthma variations within participants.

“iTREAT-PC is the first study to look at combination treatment with the antibiotic azithromycin in conjunction with inhaled corticosteroids administered as part of rescue therapy,” said David Mauger, a professor of public health sciences and statistics at the College of Medicine and Penn State Eberly College of Science, who will be leading the data coordinating center. He will join Dr. Wilson Pace from DARTNet as a co-principal investigator on the study. Lan Kong, chief of Penn State’s Division of Biostatistics and Bioinformatics, will serve as the co-investigator.

The study will include more than 3,000 asthmatic patients, ages 12 and older. Participants will be monitored for 18 months to determine which therapy is most effective for them. The research will be conducted at 10 health systems and research networks across the country. The multi-phase format will support testing and allow for refining the study’s approach.

“The design of this study involved all stakeholders including patients, clinicians and policymakers,” said Kong, professor of public health sciences. “The findings of this pragmatic trial will provide guidance on treatment options at individual levels and will be of immediate relevance to primary care clinicians and patients.” 

The iTREAT-PC study will begin a feasibility phase in 2023, and the full-scale study will launch in July 2024. This funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. 

The researchers declare no conflicts of interest or specific funding for this research.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit http://www.pcori.orgwww.pcori.org.