Comparison of Nasal Steroids After FESS in CRSwNP
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|ClinicalTrials.gov Identifier: NCT02194062|
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : March 16, 2017
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Nasal Polyps||Drug: fluticasone nasal spray Drug: Budesonide head upright Drug: Budesonide head forward||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Budesonide Nasal Irrigation in Different Head Positions and Fluticasone Nasal Spray in Post-operative Functional Endoscopic Sinus Surgery Patients With Chronic Rhinosinusitis With Nasal Polyposis|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: fluticasone nasal spray
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
Drug: fluticasone nasal spray
use 2-50 mcg sprays to each nostril two times per day
Active Comparator: budesonide respule in head upright
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Drug: Budesonide head upright
(0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Active Comparator: budesonide head forward
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.
Drug: Budesonide head forward
(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
- SNOT-22 Scores [ Time Frame: 6 months post-op. ]SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
- Lund-Kennedy Scoring for Nasal Endoscopy [ Time Frame: 6 months post-op ]The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194062
|United States, Connecticut|
|Yale Physicians Bldg|
|New Haven, Connecticut, United States, 06510|
|Yale ENT Stratford|
|Stratford, Connecticut, United States, 06614|
|Principal Investigator:||R. Peter Manes, MD||Yale University School of Medicine, Asst Professor|