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.
authors.affiliation: Allergy and Asthma Medical Group and Research Center and Department of Pediatrics, University of California, San Diego, USA.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Hamilos
authors.forename: James A
authors.initials: JA
authors.lastname: Hadley
authors.forename: Donald C
authors.initials: DC
authors.lastname: Lanza
authors.forename: Bradley F
authors.initials: BF
authors.lastname: Marple
authors.forename: Richard A
authors.initials: RA
authors.lastname: Nicklas
authors.forename: Allen D
authors.initials: AD
authors.lastname: Adinoff
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
authors.forename: Larry
authors.initials: L
authors.lastname: Borish
authors.forename: Vernon M
authors.initials: VM
authors.lastname: Chinchilli
authors.forename: Melvyn R
authors.initials: MR
authors.lastname: Danzig
authors.forename: Berrylin J
authors.initials: BJ
authors.lastname: Ferguson
authors.forename: Wytske J
authors.initials: WJ
authors.lastname: Fokkens
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Jenkins
authors.forename: Valerie J
authors.initials: VJ
authors.lastname: Lund
authors.forename: Mahmood F
authors.initials: MF
authors.lastname: Mafee
authors.forename: Robert M
authors.initials: RM
authors.lastname: Naclerio
authors.forename: Ruby
authors.initials: R
authors.lastname: Pawankar
authors.forename: Jens U
authors.initials: JU
authors.lastname: Ponikau
authors.forename: Mark S
authors.initials: MS
authors.lastname: Schubert
authors.forename: Raymond G
authors.initials: RG
authors.lastname: Slavin
authors.forename: Michael G
authors.initials: MG
authors.lastname: Stewart
authors.forename: Alkis
authors.initials: A
authors.lastname: Togias
authors.forename: Ellen R
authors.initials: ER
authors.lastname: Wald
authors.forename: Birgit
authors.initials: B
authors.lastname: Winther
mesh_terms: D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004724:Endoscopy; D006801:Humans; D009298:Nasal Polyps / Q000175:diagnosis / Q000473:pathology / Q000628:therapy; D012220:Rhinitis / Q000175:diagnosis / Q000473:pathology / Q000628:therapy; D012852:Sinusitis / Q000175:diagnosis / Q000473:pathology / Q000628:therapy