New Rhinosinusitis Clinical Trials Guidance Developed

The U.S. Food and Drug Administration (FDA) has issued specific guidance documents for designing clinical trials of certain diseases, including acute bacterial sinusitis.

More than 30 million Americans can attest that rhinosinusitis – an often recurring combination of congestion, discolored nasal discharge, cough, and headache – seriously affects their quality of life.

A group of 25 physicians from five national medical societies has collaborated to design the first clinical trial guidelines for researchers working to find the most effective treatments for rhinosinusitis.

The U.S. Food and Drug Administration (FDA) has issued specific guidance documents for designing clinical trials of certain diseases, including acute bacterial sinusitis, but there has not been a guidance document put forth for chronic rhinosinusitis clinical trials. “Rhinosinusitis: Developing Guidance for Clinical Trials,” bridges this gap and offers researchers specific recommendations for rhinosinusitis clinical trials pertaining to acute bacterial rhinosinusitis, chronic rhinosinusitis with or without nasal polyps, and allergic fungal rhinosinusitis.

The guidelines will be published in November 2006 in a supplement of the American Academy of Allergy, Asthma and Immunology’s (AAAAI) Journal of Allergy and Clinical Immunology (JACI) and in the American Academy of Otolaryngology – Head and Neck Surgery/Foundation’s (AAO-HNS/F) white journal, Otolaryngology – Head and Neck Surgery. The corresponding author is Eli O. Meltzer, MD, Co-Director, Allergy and Asthma Medical Group and Research Center, San Diego, CA.

“The goal of the Rhinosinusitis Initiative has been to provide researchers with the needed methodologies which will promote better clinical studies that can lead to improved patient care,” Meltzer said.

Key components of the guidance include:
•Reviewing FDA’s role in drug trials.
•Presenting guidance for rhinosinusitis clinical trials of antimicrobials, anti-inflammatory treatment, and symptom reliever or mediator blocker treatments.
•Recommending scoring instruments for symptoms, radiographs, endoscopic testing, and quality of life assessment.
•Recommending techniques for quantifying microbiologic factors, assessing inflammatory indices, and statistically measuring outcomes.

“Rhinosinusitis: Developing Guidance for Clinical Trials” offers a comprehensive list of rhinosinusitis clinical trial components ranging from the title of the trial, to study design, objectives and safety assessments.

The five societies involved in the collaboration include: the American Academy of Allergy, Asthma and Immunology (AAAAI); the American Academy of Otolaryngic Allergy (AAOA); the American Academy of Otolaryngology – Head and Neck Surgery/Foundation (AAO-HNS/F); the American College of Allergy, Asthma and Immunology (ACAAI); and the American Rhinologic Society (ARS).

This is the group’s second collaboration. Its original document, “Rhinosinusitis: Establishing Definitions for Clinical Research and Patient Care,” was published concurrently in the December 2004 editions of the JACI and OTO-HNS and can be found at http://journal.entnet.org. The document, which led to “Rhinosinusitis: Developing Guidance for Clinical Trials,” was a catalyst for further research on this disease. The participants in the effort agree that promoting more research on both acute and chronic rhinosinusitis is essential, and a better understanding of the cause of these diseases is needed.

Source-Newswise
SRM