Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
Information source: University of Chile
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis; Chronic Rhinosinusitis
Intervention: Prednisone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Chile Official(s) and/or principal investigator(s): Constanza J Valdes, MD, Study Director, Affiliation: University of Chile Marcela A Veloz, MD, Principal Investigator, Affiliation: University of Chile
Overall contact: Constanza J Valdes, MD, Phone: 56-02-2575-3968, Email: cjvaldes@gmail.com
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.
Clinical Details
Official title: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 monthsChange in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months
Detailed description:
General Objective:
1. Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal
polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of
symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using
Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus
standard medical treatment for 21 days.
Specific Objectives:
1. Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms
after treatment with prednisone or placebo.
2. Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy
score, after treatment with prednisone or placebo.
3. Compare improvements in smell after treatment with prednisone or placebo.
4. Determine whether there are differences in nasal permeability measured by
rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.
5. Determine whether there is a difference in the SNOT 22 questionnaire score, visual
analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP
patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving
prednisone or placebo .
6. Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue
scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with
elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E,
receiving treatment with prednisone or placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and
Nasal Polyps 2012
Exclusion Criteria:
- Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.
- Previous surgical treatment for CRSsNP
- History of diabetes mellitus and / or glaucoma and / or decompensated hypertension
and / or gastric ulcer.
- Pregnancy.
- History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic
fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.
- Hypersensitivity to prednisone
Locations and Contacts
Constanza J Valdes, MD, Phone: 56-02-2575-3968, Email: cjvaldes@gmail.com
Hospital del Salvador, Santiago, Region Metropolitana 7600490, Chile; Recruiting Constanza J Valdes, MD, Phone: 56-02-2575-3968, Email: cjvaldes@gmail.com Marcela A Veloz, MD, Phone: 56-02-2575-3968, Email: marceveloz@gmail.com Nicole S Jimenez, Sub-Investigator Felipe Cardemil, MD, Sub-Investigator
Additional Information
Related publications: 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. 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. 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. Review. 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. Benítez 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. Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21. 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. 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. Review. Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wöhrl 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. 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/Rhin. Review.
Starting date: June 2015
Last updated: June 2, 2015
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