Oral Steroid Treatment for Chronic Rhinosinusitis

Withdrawn

• Conditions: Chronic Rhinosinusitis
• Interventions: Drug: oral corticosteroid taper

• Registration Number: NCT01255683
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic rhinosinusitis	oral corticosteroid taper	-

Primary Outcome Measures

Name	Time	Method
Health-related quality-of-life	Change from baseline to 6 months	The two main outcome measures to evaluate changes in QoL include the Sinonasal Outcome Test-22 (SNOT-22) and Nasal Obstruction Scoring Evaluation (NOSE) instruments. The SNOT-22 is a validated, 22-item outcome measure applicable to both sinonasal conditions and surgical treatments (score range: 0-110). Lower total scores on the SNOT-22 imply better QoL. The SNOT-22 will be administered by the Study Coordinator to study participants at baseline, as well as 2 week, 1 month, 3 month, and 6 month follow-up appointments.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States