Oral Steroid Treatment for Chronic Rhinosinusitis

NCT ID: NCT01255683

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

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Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS), the natural history and efficacy of this treatment modality has not been fully elucidated. Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural history of endoscopic improvement and quality of life (QoL) outcomes, following an oral steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic grading, QoL, and olfactory function as well as defining the duration of improvement, in patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).

Detailed Description

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Conditions

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Chronic Rhinosinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic rhinosinusitis

oral corticosteroid taper

Intervention Type DRUG

This is an observational study in which patients self-select oral steroid treatment for symptoms of CRS. Drug treatments are NOT assigned in this investigation.

Interventions

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oral corticosteroid taper

This is an observational study in which patients self-select oral steroid treatment for symptoms of CRS. Drug treatments are NOT assigned in this investigation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult ( \> 18 years of age)
* CRS defined by 2007 Adult Sinusitis Guidelines.12
* Subject must be able to complete QoL questionnaires written in English
* Previous sinus surgery including unilateral or bilateral total ethmoidectomy
* Minimum nasal blockage score on SinoNasal Outcomes Test-22 (SNOT-22) \> 3
* Severe sinonasal inflammation where the next treatment option is a 12- day oral prednisone taper
* Obstruction of the ethmoid sinus region or middle meatus eligible for revision endoscopic sinus surgery
* Lund-Kennedy endoscopy score \> 4
* Elects 12-day tapering dose of oral steroids (Prednisone) as a next treatment option

Exclusion Criteria

* Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English
* Contra-indication to oral steroids
* Endoscopic sinus surgery \< 3 months of presentation
* Completed course of oral corticosteroids within the previous 3 month period
* Subjects presenting with unilateral chronic rhinosinusitis
* Pregnancy or possibility to become pregnant during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Oregon Health & Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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unfunded2

Identifier Type: -

Identifier Source: org_study_id

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