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

Research output: Contribution to journalArticle

185 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 languageEnglish (US)
Pages (from-to)S17-S61
JournalJournal of Allergy and Clinical Immunology
Volume118
Issue number5 SUPPL.
DOIs
StatePublished - Nov 1 2006

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Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

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