Prednisone in Chronic Rhinosinusitis Without Nasal Polyps

NCT02367118 | Unknown Phase 3

• 1 other identifier: PRD- CRSsNP-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinusitis; Chronic Rhinosinusitis

Keywords

chronic rhinosinusitis without nasal polyps prednisone

Outcome Measures

Primary Outcomes (4)

• Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months

  Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo

• Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months

  Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo

• Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months

  Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo

• Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months

  Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo

Study Arms (2)

Prednisone

EXPERIMENTAL

Intervention: prednisone 5 mg tablets taken orally, in decreasing doses. Beginning with 6 tablets (30 mg) daily for 7 days, then 3 tablets (15 mg) daily for 7 days, then 1 tablet (5 mg) daily for 7 days. Total days of treatment: 21 days.

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Intervention: placebo tablets taken orally (similar to prednisone), in decreasing doses. Beginning with 6 tablets daily for 7 days, then 3 tablets daily for 7 days, then 1 tablet daily for 7 days. Total days of treatment: 21 days.

Drug: Placebo

Interventions

Prednisone DRUG

Prednisone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello: collaborator

Study Sites (1)

Hospital del Salvador

Santiago, Santiago Metropolitan, 7600490, Chile

RECRUITING

Related Publications (16)

• 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.

  PMID: 21493210 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.

  PMID: 17882920 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.

  PMID: 19879441 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.

  PMID: 20488636 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.

  PMID: 16652085 BACKGROUND

• Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.

  PMID: 7574265 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.

  PMID: 10867835 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.

  PMID: 20599080 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.

  PMID: 23369181 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.

  PMID: 24932618 BACKGROUND

• 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.

  PMID: 22764607 RESULT

• 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.

  PMID: 24889751 RESULT

• 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.

  PMID: 24610673 RESULT

• 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.

  PMID: 24753507 RESULT

• 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.

  PMID: 22887970 RESULT

• 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.

  PMID: 22287332 RESULT

MeSH Terms

Conditions

Sinusitis

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Constanza J Valdes, MD

  University of Chile

  STUDY DIRECTOR

• Marcela A Veloz, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constanza J Valdes, MD

CONTACT

56-02-2575-3968; cjvaldes@gmail.com

Marcela A Veloz, MD

CONTACT

56-02-2575-3968; marceveloz@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor Assistant University of Chile. Department of Otorhinolaryngology-Head and Neck Surgery.

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: February 20, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

CL (1)