Oral Steroid Treatment for Chronic Rhinosinusitis

Chronic Rhinosinusitis Clinical Trial

Official title:

Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01255683
• Other study ID #: unfunded2
• Status: Withdrawn
• Phase: N/A
• First received: December 6, 2010
• Last updated: April 21, 2015
• Start date: December 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2010
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality-of-life	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.	Change from baseline to 6 months	No