Rhinosinusitis: Establishing definitions for clinical research and patient care

Background

There is a need for more research on all forms of rhinosinusitis. Progress in this area has been hampered by a lack of consensus definitions and the limited number of published clinical trials.

Objectives

To develop consensus definitions for rhinosinusitis and outline strategies useful in clinical trials.

Study design

Five national societies, The American Academy of Allergy, Asthma and Immunology; The American Academy of Otolaryngic Allergy; The American Academy of Otolaryngology Head and Neck Surgery; The American College of Allergy, Asthma and Immunology; and the American Rhinologic Society formed an expert panel from multiple disciplines. Over two days, the panel developed definitions for rhinosinusitis and outlined strategies for design of clinical trials.

Results

Committee members agreed to adopt the term “rhinosinusitis” and reached consensus on definitions and strategies for clinical research on acute presumed bacterial rhinosinusitis, chronic rhinosinusitis without polyposis, chronic rhinosinusitis with polyposis, and classic allergic fungal rhinosinusitis. Symptom and objective criteria, measures for monitoring research progress, and use of symptom scoring tools, quality-of-life instruments, radiologic studies, and rhinoscopic assessment were outlined for each condition.

Conclusions

The recommendations from this conference should improve accuracy of clinical diagnosis and serve as a starting point for design of rhinosinusitis clinical trials.

a Allergy and Asthma Medical Group and Research Center, the Department of Pediatrics, University of California, San Diego, Calif

b Division of Rheumatology, Allergy and Immunology at Massachusetts General Hospital, Boston, Mass

c Department of Otolaryngology-Head and Neck Surgery, University of Rochester, Rochester, NY

d Sinus and Nasal Institute of Florida, St Petersburg, Fla

e Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern, Dallas, Tex

f Department of Medicine, George Washington University, Washington, DC

g ENT Department, Universitair Ziekenhuis Ghent, Ghent, Belgium

i Department of Otolaryngology-Head and Neck Surgery and Pediatrics, University of Chicago, Chicago, Ill

j Department of Otolaryngology-Head and Neck Surgery, Henry Ford Hospital, Detroit, Mich

k Department of Pediatrics and Medicine, Georgetown University, Washington, DC

l Department of Allergy and Immunology, Walter Reed Army Medical Center, Washington, DC

m Division of Allergy/Immunology, the Department of Medicine, UMDNJ-New Jersey Medical School, Newark, NJ

n Department of Allergy and Respiratory Medicine, National Heart & Lung Institute, Imperial College, London, United Kingdom

o Division of Sino-nasal Disorders and Allergy, Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, Pa

p Division of Epidemiology and Virology, Department of Internal Medicine, University of Virginia School of Medicine, Charlottesville, Va

q George Washington University, School of Medicine, Institute for Asthma and Allergy, Wheaton, Md

r Department of Otolaryngology, University of Pennsylvania, Philadelphia, Pa

s Department of Otolaryngology, University College London, London, United Kingdom

t Department of Surgery, Section of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, Ill

u Department of Otolaryngology, Nippon Medical School, Tokyo, Japan

v Department of Otolaryngology and Medicine, Washington University, School of Medicine, St Louis, Mo

w Clinical Development-Inflammation, Celgene Corp, Warren, NJ

x Division of Allergy, Asthma and Immunology, Scripps Clinic, La Jolla, Calif

y Department of Internal Medicine, St Louis University, School of Medicine, St Louis, Mo

z Department of Medicine, Johns Hopkins University, School of Medicine, Baltimore, Md

aa Department of Pediatrics and Otolaryngology, University of Pittsburgh, School of Medicine, Pittsburgh, Pa

bb Department of Radiology and Radiologic Science-Neuroradiology, Johns Hopkins University, School of Medicine, Baltimore, Md

Reprint requests: Eli O. Meltzer, MD, Allergy and Asthma Medical Group and Research Center, 9610 Granite Ridge Drive, Suite B, San Diego, CA 92123

This document was edited by Dr Nicklas in his private capacity and not in his capacity as a Medical Officer with the United States Food and Drug Administration (FDA). No official support or endorsement by the FDA is intended or should be inferred.

Disclosure of potential conflict of interest: E. O. Meltzer has consulting arrangements with Alcon, Altana, AstraZeneca, Aventis, Dey, Genentech, GlaxoSmithKline, Merck, Medpointe, Novartis, Pfizer, Schering-Plough, and Wyeth; receives grants-research support from Alcon, Altana, AstraZeneca, Aventis, Dey, Genentech, GlaxoSmithKline, Merck, Novartis, Pfizer, and Schering-Plough; and is on the Speaker’s Bureau for Aventis, AstraZeneca, Genentech, GlaxoSmithKline, Merck, Pfizer, and Schering-Plough, D. L. Hamilos—none disclosed. J. Hadley has consultant arrangements with Abbott, Aventis, Bayer, GlaxoSmithKline, Merck, GE Medical Systems, Pfizer, and Schering-Plough and is on the Speaker’s Bureau for Abbott, Aventis, Bayer, GlaxoSmithKline, Merck, Pfizer, and Schering-Plough. D. Lanza is on the Speaker’s Bureau for AstraZeneca. B. F. Marple has consulting arrangements with Alcon, Aventis, and Bayer and receives grants-research support from Aventis, GlaxoSmithKline, Abbott, Merck, and Bayer. R. Nicklas—none disclosed. C. Bachert—none disclosed. J. Baraniuk has consultant arrangements with Roche, Centecor, GlaxoSmithKline, Astra-Zeneca, and Aventis; has patent-licensing arrangements with Georgetown University; receives grants-research support from the National Institutes of Health; and is employed by Georgetown University. F. M. Baroody is on the Speaker’s Bureau for Merck & Co, Inc, and GlaxoSmithKline. M. S. Benninger has consultant arrangements with Aventis, GlaxoSmithKline, Ortho-McNeil, Abbott, and Bayer; receives grants-research support from Novartis and Bayer; is on the Speaker’s Bureau for Aventis and GlaxoSmithKline. I. Brook is on the Speaker’s Bureau for Abbott. B. A. Chowdhury—none disclosed. H. M. Druce is employed by Phys Inc. S. Durham has consultant arrangements with ALK Abello, UCB, and GlaxoSmithKline; receives grants-research support from ALK Abello and GlaxoSmithKline; and is on the Speaker’s Bureau for ALK Abello, UCB, Aventis, and WAO. B. Ferguson has consulting arrangements with Aventis, Abbott, and GlaxoSmithKline; is on the Speaker’s Bureau for Aventis, Astra Zeneca, Abbott, Merck, GlaxoSmithKline, and Pfizer; and is an advisor for Pfizer. J. M. Gwaltney, Jr—none disclosed. M. Kaliner has consultant arrangements with Aventis, Novartis, GlaxoSmithKline, Genentech, and Abbott; receives grants-research support from Astra Zeneca, Aventis, Boehringer-Ingelheim, GlaxoSmithKline, and Schering-Plough; is on the Speaker’s Bureau for Aventis, Abbott, GlaxoSmithKline, Medpointe, Novartis, and Genentech. D. Kennedy has consulting arrangements with Aventis, Novartis, Medtronic-Xomed, and Schering-Plough; received grants-research support from Novartis; and has patent-licensing arrangements with Medtronic-Xomed. V. Lund has consulting arrangements with Schering-Plough and Bayer. R. Naclerio has consulting arrangements with Merck and Schering-Plough; receives grants-research support from Corixa and Merck; and is on the Speaker’s Bureau for Merck and GlaxoSmithKline. R. Pawankar—none disclosed. J. F. Piccirillo—none disclosed. P. Rohane is employed by Celgene Corp. R. Simon—none disclosed. R. Slavin has consultant arrangements with Aventis; receives grants-research support from GlaxoSmithKline, Genentech, and AstraZeneca; and is on the Speaker’s Bureau of Aventis, Schering-Plough, Genentech, and AstraZeneca. A. Togias has consultant arrangement with AstraZeneca, Genentech, GlaxoSmithKline, Novartis, and Merck; receives grants-research support from Merck and Genentech; and is on the Speaker’s Bureau for Genentech, Merck, Novartis, Pfizer, and UCB. E. R. Wald receives grants-research support from Aventis, GlaxoSmithKline, Wyeth, Abbott, and Medimmune. J. Zinreich—none disclosed.

PII: S0194-5998(04)01850-9

doi:10.1016/j.otohns.2004.09.067

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