Rhinosinusitis: Developing guidance for clinical trials.
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.
Meltzer
Eli O
EO
Allergy and Asthma Medical Group and Research Center Department of Pediatrics, University of California, San Diego, San Diego, California.
Hamilos
Daniel L
DL
Hadley
James A
JA
Lanza
Donald C
DC
Marple
Bradley F
BF
Nicklas
Richard A
RA
Adinoff
Allen D
AD
Bachert
Claus
C
Borish
Larry
L
Chinchilli
Vernon M
VM
Danzig
Melvyn R
MR
Ferguson
Berrylin J
BJ
Fokkens
Wytske J
WJ
Jenkins
Stephen G
SG
Lund
Valerie J
VJ
Mafee
Mahmood F
MF
Naclerio
Robert M
RM
Pawankar
Ruby
R
Ponikau
Jens U
JU
Schubert
Mark S
MS
Slavin
Raymond G
RG
Stewart
Michael G
MG
Togias
Alkis
A
Wald
Ellen R
ER
Winther
Birgit
B
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