drugset / Trial / NCT02367118
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
Phase 3
Unknown
90 enrolled
University of Chile
Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.
Timeline
- Start
- 2015-06
- Primary completion
- 2016-03
- Completion
- 2016-12
Publications
- Background Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.
- Background Dubin MG, Liu C, Lin SY, Senior BA. American Rhinologic Society member survey on "maximal medical therapy" for chronic rhinosinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):483-8. doi: 10.2500/ajr.2007.21.3047.
- Background Mullol J, Obando A, Pujols L, Alobid I. Corticosteroid treatment in chronic rhinosinusitis: the possibilities and the limits. Immunol Allergy Clin North Am. 2009 Nov;29(4):657-68. doi: 10.1016/j.iac.2009.07.001.
- Background Takeda K, Takeno S, Hirakawa K, Ishino T. Expression and distribution of glucocorticoid receptor isoforms in eosinophilic chronic rhinosinusitis. Auris Nasus Larynx. 2010 Dec;37(6):700-7. doi: 10.1016/j.anl.2010.03.005. Epub 2010 May 21.
- Background Benitez P, Alobid I, de Haro J, Berenguer J, Bernal-Sprekelsen M, Pujols L, Picado C, Mullol J. A short course of oral prednisone followed by intranasal budesonide is an effective treatment of severe nasal polyps. Laryngoscope. 2006 May;116(5):770-5. doi: 10.1097/01.mlg.0000205218.37514.0f.
- Background Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
- Background Kobal G, Klimek L, Wolfensberger M, Gudziol H, Temmel A, Owen CM, Seeber H, Pauli E, Hummel T. Multicenter investigation of 1,036 subjects using a standardized method for the assessment of olfactory function combining tests of odor identification, odor discrimination, and olfactory thresholds. Eur Arch Otorhinolaryngol. 2000;257(4):205-11. doi: 10.1007/s004050050223.
- Background Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.
- Background Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.
- Background Chaves C, de Andrade CR, Ibiapina C. Objective measures for functional diagnostic of the upper airways: practical aspects. Rhinology. 2014 Jun;52(2):99-103. doi: 10.4193/Rhino13.109.
- Results Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.
- Results Orlandi RR, Smith TL, Marple BF, Harvey RJ, Hwang PH, Kern RC, Kingdom TT, Luong A, Rudmik L, Senior BA, Toskala E, Kennedy DW. Update on evidence-based reviews with recommendations in adult chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Jul;4 Suppl 1:S1-S15. doi: 10.1002/alr.21344. Epub 2014 May 29.
- Results Baguley C, Brownlow A, Yeung K, Pratt E, Sacks R, Harvey R. The fate of chronic rhinosinusitis sufferers after maximal medical therapy. Int Forum Allergy Rhinol. 2014 Jul;4(7):525-32. doi: 10.1002/alr.21315. Epub 2014 Mar 7.
- Results Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.
- Results Poetker DM, Jakubowski LA, Lal D, Hwang PH, Wright ED, Smith TL. Oral corticosteroids in the management of adult chronic rhinosinusitis with and without nasal polyps: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Feb;3(2):104-20. doi: 10.1002/alr.21072. Epub 2012 Aug 7.
- Results Lal D, Hwang PH. Oral corticosteroid therapy in chronic rhinosinusitis without polyposis: a systematic review. Int Forum Allergy Rhinol. 2011 Mar-Apr;1(2):136-43. doi: 10.1002/alr.20024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |