Rhinosinusitis: Developing guidance for clinical trials

• Published in: Otolaryngology-head and neck surgery Vol. 135; no. 5 Suppl; p. S31
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: England 01.11.2006
• Subjects: Chronic Disease; Clinical Trials as Topic; Endoscopy; Humans; Nasal Polyps - diagnosis; Nasal Polyps - pathology; Nasal Polyps - therapy; Rhinitis - diagnosis; Rhinitis - pathology; Rhinitis - therapy; Sinusitis - diagnosis; Sinusitis - pathology; Sinusitis - therapy
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1016/j.otohns.2006.09.014

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.