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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 months

Change 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

Page last updated: August 23, 2015

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