PubMed · 17081855
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.
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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, Rhinosinusitis Initiative. 2006. Rhinosinusitis: Developing guidance for clinical trials.. https://doi.org/10.1016/j.otohns.2006.09.014
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