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      Rhinosinusitis: Establishing definitions for clinical research and patient care

      research-article
      , MD a , , , MD b , , MD c , , MD d , , MD e , , MD f , , MD, PhD g , , MD h , , MD i , , MD j , , MD k , , MD, PhD l , , MD m , , MD n , , MD o , , MD p , , MD q , , MD r , , MD s , , MD t , , MD, PhD u , , MD v , , MD w , , MD x , , MD, MS y , , MD z , , MD aa , , MD bb
      The Journal of Allergy and Clinical Immunology
      American Academy of Allergy, Asthma and Immunology. Published by Mosby, Inc.
      Rhinosinusitis, sinusitis, nasal polyposis, quality of life, clinical trials, AAAAI, American Academy of Allergy, Asthma and Immunology, AAO-HNS, American Academy of Otolaryngology–Head and Neck Surgery, AFRS, Allergic fungal rhinosinusitis, cfu, Colony-forming units, CNS, Coagulase-negative staphylococci, CRS, Chronic rhinosinusitis, CRSsNP, CRS without nasal polyps, CRSwNP, CRS with nasal polyps, CT, Computed tomography, ECP, Eosinophilic cationic protein, GERD, Gastroesophageal reflux disease, ICAM-1, Intercellular adhesion molecule 1, MMP, Matrix metalloproteinase, MRI, Magnetic resonance imaging, NP, Nasal polyp, PBMC, Peripheral blood mononuclear cell, PNIF, Peak flow nasal inspiratory flow, QOL, Quality of Life, RSDI, Rhinosinusitis Disability Index, RSOM-31, Rhinosinusitis Outcome Measure-31, SAE, Staphylococcus aureus enterotoxin, SERD, Supraesophageal reflux disease, SF-36, Medical Outcomes Study Short Form-36, SNOT-20, Sino-Nasal Outcome Test-20, TGF-β1, Transforming growth factor β1, Vβ, T-cell receptor variable region β chain, VCAM-1, Vascular cell adhesion molecule 1

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          Abstract

          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.

          Methods

          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.

          Conclusion

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

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          Most cited references325

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          Staging in rhinosinusitus.

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            A revised nomenclature for allergy. An EAACI position statement from the EAACI nomenclature task force.

            This report has been prepared by an EAACI task force representing the five EAACI Sections and the EAACI Executive Committee composed of specialists that reflect the broad opinion on allergy expressed by various clinical and basic specialties dealing with allergy. The aim of this report is to propose a revised nomenclature for allergic and related reactions that can be used independently of target organ or patient age group. The nomenclature is based on the present knowledge of the mechanisms which initiate and mediate allergic reactions. However, the intention has not been to revise the nomenclature of nonallergic hypersensitivity.
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              Total and specific IgE in nasal polyps is related to local eosinophilic inflammation.

              Nasal polyps (NPs) are characterized by eosinophilic inflammation and often coexist with asthma. However, the role of atopy and IgE in NP pathogenesis is unclear. We sought to determine whether there is an association between total and specific IgE to a variety of allergens in polyp and nonpolyp tissue and markers of eosinophilic inflammation or skin test results. Homogenates were prepared from nasal tissue of 20 patients with NPs and 20 patients without NPs and analyzed for concentrations of IL-5, IL-4, eotaxin, leukotriene (LT) C4/D4/E4, sCD23, and histamine (ELISA). Eosinophil cationic protein (ECP), tryptase, and total and specific IgE for inhalant allergens and Staphylococcus aureus enterotoxins were measured (ImmunoCAP). The concentrations of total IgE, IL-5, eotaxin, ECP, LTC4/D4/E4, and sCD23 were significantly higher in NP tissue compared with nonpolyp tissue. Total IgE was significantly correlated to IL-5, ECP, LTC4/D4/E4, and sCD23 and to the number of eosinophils in NPs. On the basis of the presence of specific IgE antibodies in tissue, 3 NP groups were defined. NP group 1 demonstrated no measurable specific IgE, and NP group 2 selected specific IgE. The third group demonstrated a multiclonal specific IgE, including IgE to S aureus enterotoxins, a high total IgE level, and a high prevalence of asthma. These studies suggest that there is an association between increased levels of total IgE, specific IgE, and eosinophilic inflammation in NPs, which may be of relevance in the pathophysiology of nasal polyposis. Similarly, the presence of specific IgE to staphylococcal enterotoxins A and B also points to a possible role of bacterial superantigens.
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                Author and article information

                Contributors
                Journal
                J Allergy Clin Immunol
                J. Allergy Clin. Immunol
                The Journal of Allergy and Clinical Immunology
                American Academy of Allergy, Asthma and Immunology. Published by Mosby, Inc.
                0091-6749
                1097-6825
                2 December 2004
                December 2004
                2 December 2004
                : 114
                : 6
                : 155-212
                Affiliations
                [a ]From the Department of Pediatrics, Allergy and Asthma Medical Group and Research Center, University of California, San Diego, Calif
                [b ]Division of Rheumatology, Allergy and Immunology, 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 Medical Center, Dallas, Tex
                [f ]Department of Medicine, George Washington University, Washingtion, DC
                [g ]ENT Department, Universitair Ziekenhuis Ghent, Ghent, Belgium
                [h ]Department of Medicine, Georgetown University, Washington, DC
                [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 ]Department of Medicine, the Division of Allergy/Immunology, 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 Otolaryngology–Head and Neck Surgery, University of Chicago, Department of Surgery, 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
                Author notes
                []Reprint requests: Eli O. Meltzer, MD, Allergy and Asthma Medical Group and Research Center, 9610 Granite Ridge Drive, Suite B, San Diego, CA 92123. eomeltzer@ 123456aol.com
                Article
                S0091-6749(04)02484-4
                10.1016/j.jaci.2004.09.029
                7119142
                15577865
                ff9ab010-6676-4a29-8c83-5f178865e846
                Copyright © 2004 American Academy of Allergy, Asthma and Immunology. Published by Mosby, Inc. All rights reserved.

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                History
                Categories
                Article

                Immunology
                rhinosinusitis,sinusitis,nasal polyposis,quality of life,clinical trials,aaaai, american academy of allergy, asthma and immunology,aao-hns, american academy of otolaryngology–head and neck surgery,afrs, allergic fungal rhinosinusitis,cfu, colony-forming units,cns, coagulase-negative staphylococci,crs, chronic rhinosinusitis,crssnp, crs without nasal polyps,crswnp, crs with nasal polyps,ct, computed tomography,ecp, eosinophilic cationic protein,gerd, gastroesophageal reflux disease,icam-1, intercellular adhesion molecule 1,mmp, matrix metalloproteinase,mri, magnetic resonance imaging,np, nasal polyp,pbmc, peripheral blood mononuclear cell,pnif, peak flow nasal inspiratory flow,qol, quality of life,rsdi, rhinosinusitis disability index,rsom-31, rhinosinusitis outcome measure-31,sae, staphylococcus aureus enterotoxin,serd, supraesophageal reflux disease,sf-36, medical outcomes study short form-36,snot-20, sino-nasal outcome test-20,tgf-β1, transforming growth factor β1,vβ, t-cell receptor variable region β chain,vcam-1, vascular cell adhesion molecule 1

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