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Comparison of Nasal Steroids After FESS in CRSwNP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02194062
First received: July 15, 2014
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Sinusitis Nasal Polyps Drug: fluticasone nasal spray Drug: Budesonide head upright Drug: Budesonide head forward

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 32
Study Start Date: January 2015
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • fluticasone propionate nasal
  • Flonase
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
Other Names:
  • budesonide
  • pulmicort respules
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
Other Names:
  • budesonide
  • pulmicort respules

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients who have had FESS for CRSwNP within the study period

Exclusion Criteria:

  1. Patients who are under the age of 18
  2. Concurrent oral corticosteroid use of the equivalent of greater than 10 mg of prednisone use per day
  3. The use of medications that accelerate the clearance of systemic cortisol (Dilantin, rifampin, amphetamines, and lithium)
  4. The use of medications that inhibit the clearance of systemic cortisol (ketoconazole, amphotericin B, bupropion, fluoroquinolones)
  5. Known hypersensitivity to corticosteroids
  6. A personal history of Wegener's Granulomatosis or other autoimmune disease with nasal manifestations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02194062

Locations
United States, Connecticut
Yale Physicians Bldg
New Haven, Connecticut, United States, 06510
Yale ENT Stratford
Stratford, Connecticut, United States, 06614
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: R. Peter Manes, MD Yale University School of Medicine, Asst Professor
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02194062     History of Changes
Other Study ID Numbers: pneubauer
Study First Received: July 15, 2014
Results First Received: October 19, 2016
Last Updated: January 25, 2017

Keywords provided by Yale University:
Chronic rhinosinusitis with polyps
Nasal steroids
Functional endoscopic sinus surgery
SNOT-22
Lund-Kennedy

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Fluticasone
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 18, 2017