Oral Steroid Treatment for Chronic Rhinosinusitis

NCT01255683 | Withdrawn

• 1 other identifier: unfunded2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Rhinosinusitis

Keywords

Chronic; Sinusitis; Steroid; treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Chronic rhinosinusitis

Drug: oral corticosteroid taper

Interventions

oral corticosteroid taper 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.

Chronic rhinosinusitis

Eligibility Criteria

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

Study Population

Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health \& Science University (OHSU).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Sinusitis

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 22, 2015

Record last verified: 2010-12

Locations

US (1)