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Rhinosinusitis: Developing guidance for clinical trials.
Otolaryngol Head Neck Surg. 2006 Nov; 135(5 Suppl):S31-80.OH

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

Meltzer EO
Allergy and Asthma Medical Group and Research Center Department of Pediatrics, University of California, San Diego, San Diego, California.
Hamilos DL
No affiliation info available
Hadley JA
No affiliation info available
Lanza DC
No affiliation info available
Marple BF
No affiliation info available
Nicklas RA
No affiliation info available
Adinoff AD
No affiliation info available
Bachert C
No affiliation info available
Borish L
No affiliation info available
Chinchilli VM
No affiliation info available
Danzig MR
No affiliation info available
Ferguson BJ
No affiliation info available
Fokkens WJ
No affiliation info available
Jenkins SG
No affiliation info available
Lund VJ
No affiliation info available
Mafee MF
No affiliation info available
Naclerio RM
No affiliation info available
Pawankar R
No affiliation info available
Ponikau JU
No affiliation info available
Schubert MS
No affiliation info available
Slavin RG
No affiliation info available
Stewart MG
No affiliation info available
Togias A
No affiliation info available
Wald ER
No affiliation info available
Winther B
No affiliation info available
Rhinosinusitis Initiative
No affiliation info available

MeSH

Chronic DiseaseClinical Trials as TopicEndoscopyHumansNasal PolypsRhinitisSinusitis

Pub Type(s)

Journal Article
Practice Guideline

Language

eng

PubMed ID

17081855

Clinical Trial Links

Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Citation

Meltzer, Eli O., et al. "Rhinosinusitis: Developing Guidance for Clinical Trials." Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, vol. 135, no. 5 Suppl, 2006, pp. S31-80.
Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: Developing guidance for clinical trials. Otolaryngol Head Neck Surg. 2006;135(5 Suppl):S31-80.
Meltzer, E. O., Hamilos, D. L., Hadley, J. A., Lanza, D. C., Marple, B. F., Nicklas, R. A., Adinoff, A. D., Bachert, C., Borish, L., Chinchilli, V. M., Danzig, M. R., Ferguson, B. J., Fokkens, W. J., Jenkins, S. G., Lund, V. J., Mafee, M. F., Naclerio, R. M., Pawankar, R., Ponikau, J. U., ... Winther, B. (2006). Rhinosinusitis: Developing guidance for clinical trials. Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, 135(5 Suppl), S31-80.
Meltzer EO, et al. Rhinosinusitis: Developing Guidance for Clinical Trials. Otolaryngol Head Neck Surg. 2006;135(5 Suppl):S31-80. PubMed PMID: 17081855.
* 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 - 2006/11/4/pubmed PY - 2007/4/20/medline PY - 2006/11/4/entrez SP - S31 EP - 80 JF - Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery JO - Otolaryngol Head Neck Surg VL - 135 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 - 0194-5998 UR - https://www.unboundmedicine.com/medline/citation/17081855/Rhinosinusitis:_Developing_guidance_for_clinical_trials_ DB - PRIME DP - Unbound Medicine ER -