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 & 5 others Raymond G. Slavin, Michael G. Stewart, Alkis Togias, Ellen R. Wald, Birgit Winther

Research output: Contribution to journalArticle

72 Citations (Scopus)

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 languageEnglish (US)
JournalOtolaryngology - Head and Neck Surgery
Volume135
Issue number5 SUPPL.
DOIs
StatePublished - Nov 2006

Fingerprint

Nasal Polyps
Clinical Trials
Microbiology
Nose
Endoscopy
Publications
Patient Care
Anti-Inflammatory Agents
Health
Research
Therapeutics

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

Meltzer, E. O., Hamilos, D. L., Hadley, J. A., Lanza, D. C., Marple, B. F., Nicklas, R. A., ... Winther, B. (2006). Rhinosinusitis: Developing guidance for clinical trials. Otolaryngology - Head and Neck Surgery, 135(5 SUPPL.). https://doi.org/10.1016/j.otohns.2006.09.014

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

In: Otolaryngology - Head and Neck Surgery, Vol. 135, No. 5 SUPPL., 11.2006.

Research output: Contribution to journalArticle

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', Otolaryngology - Head and Neck Surgery, vol. 135, no. 5 SUPPL.. https://doi.org/10.1016/j.otohns.2006.09.014
Meltzer, Eli O. ; Hamilos, Daniel L. ; Hadley, James A. ; Lanza, Donald C. ; Marple, Bradley F. ; Nicklas, Richard A. ; Adinoff, Allen D. ; Bachert, Claus ; Borish, Larry ; Chinchilli, Vernon M. ; Danzig, Melvyn R. ; Ferguson, Berrylin J. ; Fokkens, Wytske J. ; Jenkins, Stephen G. ; Lund, Valerie J. ; Mafee, Mahmood F. ; Naclerio, Robert M. ; Pawankar, Ruby ; Ponikau, Jens U. ; Schubert, Mark S. ; Slavin, Raymond G. ; Stewart, Michael G. ; Togias, Alkis ; Wald, Ellen R. ; Winther, Birgit. / Rhinosinusitis : Developing guidance for clinical trials. In: Otolaryngology - Head and Neck Surgery. 2006 ; Vol. 135, No. 5 SUPPL.
@article{059579b2900743e39a7273607b1ca6db,
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.",
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 = "11",
doi = "10.1016/j.otohns.2006.09.014",
language = "English (US)",
volume = "135",
journal = "Otolaryngology - Head and Neck Surgery (United States)",
issn = "0194-5998",
publisher = "Mosby Inc.",
number = "5 SUPPL.",

}

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.

UR - http://www.scopus.com/inward/record.url?scp=33750479491&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33750479491&partnerID=8YFLogxK

U2 - 10.1016/j.otohns.2006.09.014

DO - 10.1016/j.otohns.2006.09.014

M3 - Article

VL - 135

JO - Otolaryngology - Head and Neck Surgery (United States)

JF - Otolaryngology - Head and Neck Surgery (United States)

SN - 0194-5998

IS - 5 SUPPL.

ER -