Clinical trial NCT02194062
Conditions: Sinusitis Nasal Polyps
Keywords: Chronic rhinosinusitis with polyps Nasal steroids Functional endoscopic sinus surgery SNOT-22 Lund-Kennedy
Sponsor: Yale University
Start date: 2015-01-01; Completion date: 2015-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.

Detailed description:
Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1). CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus. Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic sinus surgery.

Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies have shown that nasal steroids are superior to placebo in maintaining improvement in symptom scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal steroids can reduce inflammation locally and can prevent disease relapse without the systemic effects of oral steroids. However, there is no consensus as to which nasal steroid and which delivery method is most effective in treating these patients. Traditional nasal sprays, such as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide is available in a respule form that can be used to instill the medication in the nose. In an attempt to more effectively deliver the medication, changes in patient's head position has been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy over fluticasone nasal spray remains anecdotal as head to head comparisons have not previously been performed.

Practice patterns among rhinologists in the post-operative prescription of nasal steroids vary widely. Determining which medication/delivery method is more effective will help rhinologists better treat their patients and prevent symptoms, for which the surgery was performed, from returning.

Arms: arm 1: Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day) arm 2: Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day arm 3: Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Interventions: intervention 1: fluticasone nasal spray intervention 2: Budesonide head upright intervention 3: Budesonide head forward
Intervention descriptions: intervention 1: use 2-50 mcg sprays to each nostril two times per day intervention 2: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day intervention 3: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day

Protocol documents: