Rhinosinusitis: Developing guidance for clinical trials

Eli O. Meltzer; Daniel L. Hamilos; James A. Hadley; Donald C. Lanza; Bradley F. Marple; Richard A. Nicklas; Allen D. Adinoff; Claus Bachert; Larry Borish; Vernon M. Chinchilli; Melvyn R. Danzig; Berrylin J. Ferguson; Wytske J. Fokkens; Stephen G. Jenkins; Valerie J. Lund; Mahmood F. Mafee; Robert M. Naclerio; Ruby Pawankar; Jens U. Ponikau; Mark S. Schubert; Raymond G. Slavin; Michael G. Stewart; Alkis Togias; Ellen R. Wald; Birgit Winther

doi:10.1016/j.jaci.2006.09.005

Rhinosinusitis: Developing guidance for clinical trials

Eli O. Meltzer
, Daniel L. Hamilos
, James A. Hadley
, Donald C. Lanza
, Bradley F. Marple
, Richard A. Nicklas
, Allen D. Adinoff
, Claus Bachert
, Larry Borish
, Vernon M. Chinchilli
, Melvyn R. Danzig
, Berrylin J. Ferguson
, Wytske J. Fokkens
, Stephen G. Jenkins
, Valerie J. Lund
, Mahmood F. Mafee
, Robert M. Naclerio
, Ruby Pawankar
, Jens U. Ponikau
, Mark S. Schubert

Raymond G. Slavin, Michael G. Stewart, Alkis Togias, Ellen R. Wald, Birgit Winther

Department of Otolaryngology

University at Buffalo

Research Center
Massachusetts General Hospital
University of Rochester
PA
University of Texas Southwestern Medical Center
George Washington University
University of Colorado Anschutz Medical Campus
Ghent University
Asthma and Allergic Diseases Center
Pennsylvania State University
Merck
University of Pittsburgh
Amsterdam University Medical Center
Icahn School of Medicine at Mount Sinai
University College London
University of California at San Diego
The University of Chicago
Nippon Medical School
University of Arizona
Saint Louis University
Cornell University
Johns Hopkins University
University of Wisconsin-Madison
University of Virginia

Research output: Contribution to journal › Article › peer-review

319 Scopus citations

Abstract

The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication "Rhinosinusitis: Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

Original language	English
Pages (from-to)	S17-S61
Journal	Journal of Allergy and Clinical Immunology
Volume	118
Issue number	5 SUPPL.
DOIs	https://doi.org/10.1016/j.jaci.2006.09.005
State	Published - Nov 2006

Keywords

Acute bacterial rhinosinusitis
allergic fungal rhinosinusitis
chronic rhinosinusitis with or without polyps
clinical trials

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10.1016/j.jaci.2006.09.005

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Meltzer, E. O., Hamilos, D. L., Hadley, J. A., Lanza, D. C., Marple, B. F., Nicklas, R. A., Adinoff, A. D., Bachert, C., Borish, L., Chinchilli, V. M., Danzig, M. R., Ferguson, B. J., Fokkens, W. J., Jenkins, S. G., Lund, V. J., Mafee, M. F., Naclerio, R. M., Pawankar, R., Ponikau, J. U., ... Winther, B. (2006). Rhinosinusitis: Developing guidance for clinical trials. Journal of Allergy and Clinical Immunology, 118(5 SUPPL.), S17-S61. https://doi.org/10.1016/j.jaci.2006.09.005

@article{a3b6decc01404fd583f700e6400e036b,

title = "Rhinosinusitis: Developing guidance for clinical trials",

abstract = "The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication {"}Rhinosinusitis: Establishing definitions for clinical research and patient care{"} and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.",

keywords = "Acute bacterial rhinosinusitis, allergic fungal rhinosinusitis, chronic rhinosinusitis with or without polyps, clinical trials",

author = "Meltzer, \{Eli O.\} and Hamilos, \{Daniel L.\} and Hadley, \{James A.\} and Lanza, \{Donald C.\} and Marple, \{Bradley F.\} and Nicklas, \{Richard A.\} and Adinoff, \{Allen D.\} and Claus Bachert and Larry Borish and Chinchilli, \{Vernon M.\} and Danzig, \{Melvyn R.\} and Ferguson, \{Berrylin J.\} and Fokkens, \{Wytske J.\} and Jenkins, \{Stephen G.\} and Lund, \{Valerie J.\} and Mafee, \{Mahmood F.\} and Naclerio, \{Robert M.\} and Ruby Pawankar and Ponikau, \{Jens U.\} and Schubert, \{Mark S.\} and Slavin, \{Raymond G.\} and Stewart, \{Michael G.\} and Alkis Togias and Wald, \{Ellen R.\} and Birgit Winther",

year = "2006",

month = nov,

doi = "10.1016/j.jaci.2006.09.005",

language = "English",

volume = "118",

pages = "S17--S61",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Elsevier Inc.",

number = "5 SUPPL.",

}

Meltzer, EO, Hamilos, DL, Hadley, JA, Lanza, DC, Marple, BF, Nicklas, RA, Adinoff, AD, Bachert, C, Borish, L, Chinchilli, VM, Danzig, MR, Ferguson, BJ, Fokkens, WJ, Jenkins, SG, Lund, VJ, Mafee, MF, Naclerio, RM, Pawankar, R, Ponikau, JU, Schubert, MS, Slavin, RG, Stewart, MG, Togias, A, Wald, ER & Winther, B 2006, 'Rhinosinusitis: Developing guidance for clinical trials', Journal of Allergy and Clinical Immunology, vol. 118, no. 5 SUPPL., pp. S17-S61. https://doi.org/10.1016/j.jaci.2006.09.005

TY - JOUR

T1 - Rhinosinusitis

T2 - Developing guidance for clinical trials

AU - Meltzer, Eli O.

AU - Hamilos, Daniel L.

AU - Hadley, James A.

AU - Lanza, Donald C.

AU - Marple, Bradley F.

AU - Nicklas, Richard A.

AU - Adinoff, Allen D.

AU - Bachert, Claus

AU - Borish, Larry

AU - Chinchilli, Vernon M.

AU - Danzig, Melvyn R.

AU - Ferguson, Berrylin J.

AU - Fokkens, Wytske J.

AU - Jenkins, Stephen G.

AU - Lund, Valerie J.

AU - Mafee, Mahmood F.

AU - Naclerio, Robert M.

AU - Pawankar, Ruby

AU - Ponikau, Jens U.

AU - Schubert, Mark S.

AU - Slavin, Raymond G.

AU - Stewart, Michael G.

AU - Togias, Alkis

AU - Wald, Ellen R.

AU - Winther, Birgit

PY - 2006/11

Y1 - 2006/11

N2 - The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication "Rhinosinusitis: Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

AB - The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication "Rhinosinusitis: Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

KW - Acute bacterial rhinosinusitis

KW - allergic fungal rhinosinusitis

KW - chronic rhinosinusitis with or without polyps

KW - clinical trials

UR - https://www.scopus.com/pages/publications/33750432176

U2 - 10.1016/j.jaci.2006.09.005

DO - 10.1016/j.jaci.2006.09.005

M3 - Article

C2 - 17084217

SN - 0091-6749

VL - 118

SP - S17-S61

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 5 SUPPL.

ER -

Rhinosinusitis: Developing guidance for clinical trials

Abstract

Keywords

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