Rhinosinusitis: Developing guidance for clinical trials Review uri icon

Overview

MeSH Major

  • Clinical Trials as Topic
  • Rhinitis
  • Sinusitis

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.

publication date

  • November 2006

Research

keywords

  • Review

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1016/j.jaci.2006.09.005

PubMed ID

  • 17084217

Additional Document Info

start page

  • S17

end page

  • 61

volume

  • 118

number

  • 5 SUPPL.