Rhinosinusitis: Developing guidance for clinical trials - 16/08/11
San Diego, Calif, Boston, Mass, Rochester, New York, and Buffalo, NY, St Petersburg, Fla, Dallas, Tex, Washington, DC, Denver, Colo, Ghent, Belgium, Charlottesville, Va, Hershey and Pittsburgh, Pa, Kenilworth, NJ, Amsterdam, The Netherlands, London, United Kingdom, Chicago, Ill, Tokyo, Japan, Phoenix, Arizona, St Louis, Missouri, Baltimore, Md, and Madison, Wis
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.
Le texte complet de cet article est disponible en PDF.Key words : Acute bacterial rhinosinusitis, chronic rhinosinusitis with or without polyps, allergic fungal rhinosinusitis, clinical trials
Abbreviations used : ABRS, AE, AE-CRS, AFRS, AR, CRS, CRSsNP, CRSwNP, CT, ECG, FDA, iNOS, INS, LT, MRI, NO, NP, PK, QOL, SNOT-20, TSS, URI
Plan
| Disclosure of potential conflict of interest: E. O. Meltzer has consultant arrangements with Abbott, Adelphi, Alcon, Allux, Altana, Amgen, AstraZeneca, Capnia, Critical Therapeutics, Dey, Evolutec, Genentech, GlaxoSmithKline, Greer, Inspire, KOS, MedPointe, Merck, Novartis, Pfizer, Rigel, Sanofi-Aventis, Schering-Plough, Shionogi, Verus, and Wyeth; has received grant support from Alcon, Allux, Altana, AstraZeneca, Clay-Park, Critical Therapeutics, Genentech, GlaxoSmithKline, Hoffman-La Roche, Medicinova, MedPointe, Merck, Novartis, Pharmaxis, Rigel, Sanofi-Aventis, Schering-Plough, and Wyeth; is employed by the Allergy and Asthma Medical Group and Research Center; and is on the speakers’ bureau for AstraZeneca, Alcon, Altana, Genentech, Genesis, GlaxoSmithKline, MedPointe, Merck, Pfizer, Sanofi-Aventis, Schering-Plough, and Verus. D. L. Hamilos has consultant arrangements with Sinexus, Accentia, Isis, Novartis, Schering, and Genentech and is on the speakers’ bureau for Merck and Genentech. J. A. Hadley has consultant arrangements with Altana Pharmaceuticals, Abbott Laboratories, GE Medical Systems, Replidyne, and Critical Therapeutics; has received grant support from Abbott and Sanofi-Aventis; and is on the speakers’ bureau for GlaxoSmithKline, Schering-Plough, Ortho McNeil, and Sanofi-Aventis. B. F. Marple has consulting arrangements with Allux, Novecol, Alcon, ALK-Abelló, Pfizer, Medtimix, and Replidyne; owns stock in Allux and Novecol; and is on the speakers’ bureau for Sanofi-Aventis, Merck, and Pfizer. L. Borish has consultant arrangement with Genentech, Isis, Sepracor, Syngenta, Protein Design Lab, Critical Therapeutics, and Novartis; has received grant support from GlaxoSmithKline; and is on the speakers’ bureau for Critical Therapeutics and Merck. M. R. Danzig has consultant arrangements with Schering-Plough and owns stock in Schering-Plough and Merck. B. Ferguson has consultant arrangements with GlaxoSmithKline, Sanofi-Aventis, and Altana; has received grant support from Naryx, MedPointe, Novartis, and GlaxoSmithKline; and is on the speakers’ bureau for Schering-Plough, Sanofi-Aventis, GlaxoSmithKline, and Merck. W. J. Fokkens has consultant arrangements with GlaxoSmithKline and Schering-Plough and has received grant support from GlaxoSmithKline, Schering-Plough, ALK, HAL, and Philips. S. G. Jenkins has consultant arrangements with Nektar Therapeutics and Hoffman-La Roche and is on the speakers’ bureau for Sanofi-Aventis, OrthoMcNeil, Wyeth, Cobist, and Schering-Plough. V. J. Lund has consultant arrangements with Schering-Plough and has received grant support from GlaxoSmithKline. R. M. Naclerio has consultant arrangements with Merck, GlaxoSmithKline, and Schering-Plough; has received grant support from Merck, GlaxoSmithKline, Schering-Plough, Alcon, and Novartis; and is on the speakers’ bureau for Aventis, Schering-Plough, and Merck. J. U. Ponikau has patent licensing arrangements with the Mayo Foundation and has testified once for a patient in mold litigation (all proceeds were donated to charity). M. S. Schubert is on the speakers’ bureau for Merck. R. G. Slavin has consultant arrangements with Schering-Plough, Merck, and Dey and is on the speakers’ bureau for Merck, Genentech, and Novartis. A. Togias has consultant arrangements with AirPharma, Altana, Genentech, GlaxoSmithKline, MedPointe, Merck, and Novartis and is on the speakers’ bureau for Genentech, Merck, and Novartis. The rest of the authors declare that they have no conflict of interest. |
Vol 118 - N° 5S
P. S17-S61 - novembre 2006 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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