Researchers to explore treatments for acute rhinosinusitis in clinical trial

Pennsylvania State University

HERSHEY, Pa. - Penn State faculty are joining clinical researchers from across the country to study treatment approaches to acute rhinosinusitis, also called "sinusitis." The condition is an inflammation of the nose and sinus passages most often caused by a viral or bacterial infection that affects one in seven U.S. adults each year. Optimal therapy, particularly concerning when to prescribe antibiotics, is not well known.

The Patient-Centered Outcomes Research Institute (PCORI) awarded a Georgetown University Medical Center research team led by Dr. Dan Merenstein, professor of family medicine and of human science, funds to lead a multi-site study of treatments for acute rhinosinusitis. Dr. David Rabago, professor and vice chair for faculty development in the Department of Family and Community Medicine, will lead Penn State College of Medicine's involvement in the $23.6 million clinical trial. Dr. Aleksandra Zgierska and Wen-Jan Tuan, both faculty in the Department of Family and Community Medicine, are also contributing to the study.

"Acute rhinosinusitis leaves people feeling miserable and desperate for relief, and their care providers eager to help," said Merenstein, director of research programs for Georgetown's Department of Family Medicine. "Unfortunately, in the absence of clinically proven treatments, providers often prescribe antibiotics. We want to know if there's a better way to treat patients and alleviate symptoms quicker, while also figuring out who really benefits from antibiotics and should take them as soon as possible."

Acute rhinosinusitis symptoms often include congestion, headaches, sinus pressure, facial pain and a green or yellow nasal discharge. In the U.S., one in seven adults every year is diagnosed with acute rhinosinusitis (totaling 30 million office visits), leading to antibiotics prescribed to one in five of those adults. In addition to antibiotics, nasal sprays such as intranasal corticosteroids (INCS), over-the-counter supportive treatment or saline nasal irrigation (SNI) may help improve symptoms.

"Our study goal is to understand what treatment approaches are best at improving outcomes for patients," Merenstein explained. "Do antibiotics really improve the course of symptoms, or are options such as nasal irrigation or nasal sprays with a corticosteroid more effective? We hope the information we learn in this study can be used by providers and those suffering from this tough to treat condition."

Engaging the community

During their application review, PCORI asked the research team to include more information about patient perspectives on acute sinusitis. Rabago said he knew exactly where to turn for this critical support - Penn State Clinical and Translational Science Institute.

The team engaged the Institute's Community-Engaged Research Core, co-directed by Zgierska, to solicit feedback via a survey administered during a virtual community engagement studio that included the perspectives of 46 patient stakeholders.

"Community members served by Penn State Health indicated that acute sinusitis and a better understanding of its treatment are relevant to them," said Rabago. "Many people expressed a desire for better guidance about acute rhinosinusitis treatment approaches and for whom and when antibiotics could be beneficial."

Andrea Murray, community engagement director at the College of Medicine, said that community input on research related to new treatments and health discoveries ensures that studies are more effective and meaningful for those they are intended to reach.

"Community engagement and collaboration are essential to our success at Penn State," Murray said. "These stakeholders provide valuable feedback on research concepts or study designs before we dedicate valuable time and resources to a project. We want to make sure the research will have a meaningful impact on their health and lives."

Other collaborators on the project include researchers from the MedStar Health Research Institute, University of Washington, University of California Los Angeles, Virginia Commonwealth University and the University of Wisconsin. Together, the investigators will recruit more than 3,700 people diagnosed with acute rhinosinusitis to the largest clinical trial of its kind to study various treatment approaches.

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 health care decisions.

Merenstein's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

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