Rhinosinusitis: Developing guidance for clinical trials

被引：298

作者：

Meltzer, Eli O.

Hamilos, Daniel L.

Hadley, James A.

Lanza, Donald C.

Marple, Bradley F.

Nicklas, Richard A.

Adinoff, Allen D.

Bachert, Claus

Borish, Larry

Chinchilli, Vernon M.

Danzig, Melvyn R.

Ferguson, Berrylin J.

Fokkens, Wytske J.

Jenkins, Stephen G.

Lund, Valerie J.

Mafee, Mahmood F.

Naclerio, Robert M.

Pawankar, Ruby R.

Ponikau, Jens U.

Schubert, Mark S.

Slavin, Raymond G.

Stewart, Michael G.

Togias, Alkis

Wald, Ellen R.

Winther, Birgit

机构：

[1] Allergy and Asthma Medical Group, Research Center, the Department of Pediatrics

[2] Department of Radiology, University of California, San Diego

[3] Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston

[4] Department of Otolaryngology, University of Rochester Medical Center, Rochester

[5] Sinus and Nasal Institute of Florida, PA, St Anthony's Carillon Outpatient and Wellness Center, St Petersburg

[6] Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas

[7] Department of Medicine, George Washington Medical Center, WA

[8] Department of Pediatrics and Pharmacology, University of Colorado Health Sciences, Denver

[9] ENT Clinic, University Hospital, Ghent

[10] Department of Medicine, Asthma and Allergic Diseases Center

[11] Department of Otolaryngology, University of Virginia Health System, Charlottesville

[12] Department of Health Evaluation Science, Penn State College of Medicine, Hershey

[13] Schering-Plough Research Institute, Kenilworth

[14] Division of Sino-nasal Disorder and Allergy, Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh School of Medicine, Pittsburgh

[15] ENT Department, Academic Medical Centre Hospital, University of Amsterdam, Amsterdam

[16] Clinical Microbiology Laboratories, Mount Sinai Medical Center, NY

[17] Department of Rhinology, University College London, London

[18] Department of Otolaryngology-Head and Neck Surgery, University of Chicago

[19] Nippon Medical School, Tokyo

[20] Department of Otolaryngology, University of Buffalo (The State University of New York)

[21] Department of Medicine, University of Arizona, Phoenix and Tucson, Phoenix

[22] Department of Internal Medicine, St Louis University School of Medicine

[23] Department of Otolaryngology, Weill Cornell Medical College, NY

[24] Department of Medicine, Johns Hopkins University School of Medicine, Baltimore

[25] Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison

来源：

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY | 2006年 / 118卷 / 05期

关键词：

acute bacterial rhinosinusitis; chronic rhinosinusitis with or without polyps; allergic fungal rhinosinusitis; clinical trials;

D O I：

10.1016/j.jaci.2006.09.005

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

Rhinosinusitis Initiative was developed by 5 national clinical research and patient care" and provides templates for societies. The current guidance document is an expansion of the clinical trials in antimicrobial, anti-inflammatory, and 2004 publication "Rhinosinusitis: Establishing definitions for 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.

引用

页码：S17 / S61

页数：45

共 146 条

[1] Clinimetric evaluation of the Sinonasal Outcome Test-16 [J].