Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

NCT01676415 | Terminated Phase 4 Results

• 1 other identifier: 18369
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the most effective route to administer steroids to patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with nasal polyps (CRSsNP). The investigators would like to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators propose to test the hypothesis that for patients with radiographically proven CRSsNP, routine medical therapy consisting of a short course of systemic corticosteroids is superior to topical corticosteroids for relieving inflammation and the symptoms of CRS.

Conditions

Chronic Rhinosinusitis Without Nasal Polyps

Keywords

Sinus disease; Sinonasal complaints; Chronic sinusitis; Nasal polyps; Chronic rhinosinusitis without nasal polyps; Glucocorticoids; Prednisone; Topical mometasone; Anti-inflammatory agents

Outcome Measures

Primary Outcomes (1)

• SNOT-22 Questionnaire

  The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms ("nasal obstruction" and "loss of smell and taste") ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 ("worst possible problem" on all symptoms) Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.

  4-6 weeks and 3 months after initiation of treatment

Secondary Outcomes (3)

• Lund-McKay Score From CT Scan

  4-6 weeks and 3 months after initiation of treatment

• Taskforce Symptom Inventory

  4-6 weeks and 3 months after initiation of treatment

• Medication Side-effect and Compliance Inventory

  4-6 weeks and 3 months after initiation of treatment

Study Arms (2)

Prednisone

ACTIVE COMPARATOR

Oral steroid medication

Drug: Prednisone

Topical Mometasone

ACTIVE COMPARATOR

Topical steroid medication

Drug: Topical mometasone

Interventions

Prednisone DRUG

Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead Antihistamines if an appropriate history of atopy is obtained Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study

Also known as: Glucocorticoid, Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS

Prednisone

Topical mometasone DRUG

Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead Antihistamines if an appropriate history of atopy is obtained Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.

Topical Mometasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the Taskforce on Rhinosinusitis.
• They have a CT-scan in our clinic or have a viewable recent (\< 3weeks prior to clinic visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay score of 6 or greater is felt to be indicative of at least moderate CRS.
• They do not have nasal polyps on initial clinic nasal endoscopy
• They are willing to participate in a clinical study
• They are between the ages of 18 to 80.

You may not qualify if:

• They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
• They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
• They have been treated with a \> 3 week course of antibiotics and/or systemic steroids will also be excluded.
• They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
• They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
• They have nasal polyps on physical exam.
• They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
• They have a Lund-Mckay score on CT scan of \< 6
• They are \< 18 or \> 80 years old

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

: Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.

  PMID: 16815148 BACKGROUND

• Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.

  PMID: 17903570 BACKGROUND

• Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

  PMID: 19793277 BACKGROUND

• Parikh A, Scadding GK, Darby Y, Baker RC. Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray. Rhinology. 2001 Jun;39(2):75-9.

  PMID: 11486442 BACKGROUND

• Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.

  PMID: 12862401 BACKGROUND

• Wallwork B, Coman W, Mackay-Sim A, Greiff L, Cervin A. A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis. Laryngoscope. 2006 Feb;116(2):189-93. doi: 10.1097/01.mlg.0000191560.53555.08.

  PMID: 16467702 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Paranasal Sinus Diseases; Nasal Polyps

Interventions

Prednisone; Glucocorticoids; Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.

Results Point of Contact

• Title: BRUCE TAN
• Organization: NORTHWESTERN UNIVERSITY

CPRICE2@NM.ORG

3126958182

Study Officials

• Bruce Tan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 30, 2018
• Results First Posted: May 8, 2017

Record last verified: 2018-03

Locations

US (1)