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Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

NCT01676415 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-03-30

Study results available
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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

Interventions

DRUG

Prednisone

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

DRUG

Topical mometasone

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.

Sponsors & Collaborators

Principal Investigators

  • Bruce Tan, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-01-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676415 on ClinicalTrials.gov