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Rhinosinusitis: developing guidance for clinical trials.
J Allergy Clin Immunol 2006; 118(5 Suppl):S17-61JA

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+Show Affiliations

Allergy and Asthma Medical Group and Research Center and Department of Pediatrics, University of California, San Diego, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Practice Guideline

Language

eng

PubMed ID

17084217

Citation

Meltzer, Eli O., et al. "Rhinosinusitis: Developing Guidance for Clinical Trials." The Journal of Allergy and Clinical Immunology, vol. 118, no. 5 Suppl, 2006, pp. S17-61.
Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006;118(5 Suppl):S17-61.
Meltzer, E. O., Hamilos, D. L., Hadley, J. A., Lanza, D. C., Marple, B. F., Nicklas, R. A., ... Winther, B. (2006). Rhinosinusitis: developing guidance for clinical trials. The Journal of Allergy and Clinical Immunology, 118(5 Suppl), pp. S17-61.
Meltzer EO, et al. Rhinosinusitis: Developing Guidance for Clinical Trials. J Allergy Clin Immunol. 2006;118(5 Suppl):S17-61. PubMed PMID: 17084217.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rhinosinusitis: developing guidance for clinical trials. AU - Meltzer,Eli O, AU - Hamilos,Daniel L, AU - Hadley,James A, AU - Lanza,Donald C, AU - Marple,Bradley F, AU - Nicklas,Richard A, AU - Adinoff,Allen D, AU - Bachert,Claus, AU - Borish,Larry, AU - Chinchilli,Vernon M, AU - Danzig,Melvyn R, AU - Ferguson,Berrylin J, AU - Fokkens,Wytske J, AU - Jenkins,Stephen G, AU - Lund,Valerie J, AU - Mafee,Mahmood F, AU - Naclerio,Robert M, AU - Pawankar,Ruby, AU - Ponikau,Jens U, AU - Schubert,Mark S, AU - Slavin,Raymond G, AU - Stewart,Michael G, AU - Togias,Alkis, AU - Wald,Ellen R, AU - Winther,Birgit, AU - ,, PY - 2006/07/31/received PY - 2006/08/25/revised PY - 2006/09/01/accepted PY - 2006/11/7/pubmed PY - 2007/4/6/medline PY - 2006/11/7/entrez SP - S17 EP - 61 JF - The Journal of allergy and clinical immunology JO - J. Allergy Clin. Immunol. VL - 118 IS - 5 Suppl N2 - 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. SN - 0091-6749 UR - https://www.unboundmedicine.com/medline/citation/17084217/Rhinosinusitis:_developing_guidance_for_clinical_trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091-6749(06)01907-5 DB - PRIME DP - Unbound Medicine ER -