Multispecialty Consortium Introduces Rhinosinusitis Clinical Trial Guidelines.

Two of the guideline participants, Dr. Meltzer and Bradley F. Marple, MD, commented in separate telephone interviews regarding the ways the guidelines will help researchers in rhinosinusitis.

New Treatment Modalities Needed

The diseases of the respiratory tract seem to be increasing across the world, and there is no magic potion to cure them, said Dr. Meltzer. Therefore, we need to develop new treatment modalities, pharmacologic, immunologic, surgical modalities, to improve people’s health.

Despite this urgent need, to date, there is no good road map to develop new treatments for sinus disease, he added. There has been guidance for clinical trial programs for rhinitis and asthma, but not for sinusitis. Therefore, thought leaders in allergy and in otolaryngology addressed the void in 2002 by forming the Rhinosinusitis Initiative, whose mission has been to develop better definitions and methodologies to document the efficacy of any intervention in rhinosinusitis, he said.

Most recent publications give guidance for specific methodologies regarding how to design trials in rhinosinusitis, he said. These range from inclusion criteria and exclusion criteria to ways for documenting how an intervention can be helpful and the magnitude of the benefit of the intervention.

The consortium considers the next important step to be the development by the Food and Drug Administration (FDA) of a clinical trial guidance for using the consortium’s guideline that is accepted by the research community and industry, he said.

Building on the Initiative’s History

Noting the importance of the history of the Rhinosinusitis Initiative, Dr. Marple, Professor and Vice-Chair of the Department of Otolaryngology at University of Texas Southwestern Medical School in Dallas, stressed that the most recent publication is the second part of a work in progress that is centered around improving our understanding of what underlies chronic rhinosinusitis and the therapies that would improve outcomes. He continued, The first document focused on defining the condition as a disease entity and identifying subsets within chronic rhinosinusitis. The second document recommends ways for evaluating different interventions for different subsets in an effort to best coordinate research efforts.

The Rhinosinusitis Initiative hopes that the guideline will help to standardize the approach by which these different interventions could be studied in different subsets, he said. The guideline consists of templates that are relatively versatile but revolve around a common theme: the type of intervention and the type of disease process.

Four Major Protocols

From this perspective, the Rhinosinusitis Initiative outlined four major protocol designs.