Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps (dexamethasone)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Kristin Seiberling, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01777906
First received: January 24, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps. Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary medical management to prevent continued growth. More recently high dose topical nasal steroid sprays are used. It is thought that the higher dose will penetrate the sinus cavities at an increased dose and will allow for greater control of polyp growth. Safety studies have been performed which have shown no suppression of the pituitary axis with long term high dose topical steroid or changes in intraocular pressure. However, studies in efficacy are limited despite their widespread use. The objective of this study will be to compare the effectiveness of two topical nasal steroid sprays in patients with recurrent nasal polyps.


Condition
Size of Nasal Polyps
Control of Symptoms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Topical Nasal Steroids in Postoperative Sinus Patients With Nasal Polyps

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Comparison of topical nasal steroids in postoperative sinus patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Primary outcome will be symptomatic improvement measured by the SNOT 20 survey and physical size of polyps as measured by nasal endoscopy.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fluticasone
Fluticasone nasal spray will be given 2 sprays twice a day for 6 weeks.
Dexamethasone sodium phosphate 0.032%
Dexamethasone 0.032% nasal spray will be given at a dose of 2 sprays twice a day for 6 weeks.

Detailed Description:

Recruitment plan- Patients with nasal polyps who have had sinus surgery at least 3 months prior and documented nasal polyps by endoscopy will be prospectively recruited. This will be a randomized blinded study. Patients will be randomized into two groups- group 1 will received topical fluticasone and group 2 will receive topical dexamethasone spray to the nasal cavity. The investigator will be blinded as to which group the subjects are placed in. The medications will be given out from the inland compounding pharmacy located at 24747 Redlands Blvd, in Loma Linda.

Procedures

  1. At the time of enrollment nasal endoscopy will be performed to confirm the diagnosis of nasal polyps and to grade the size of the polyps. Polyp size will be graded by the following scale: 0- no polyps, 1- polypoid mucosa, 2- polyps within sinus not occluding ostium, 3- polyps occluding ostium filling nasal cavity
  2. Subjects will be asked to fill out a SNOT 20 survey before the start of therapy.
  3. Subjects will be randomized into 2 groups by the flip of a coin. The investigator will be blinded to which group the subject is placed in. The pharmacist (Raylene Mote, Inland compounding pharmacy) who compounds the medications will be the only one aware of which medication was given.
  4. Subjects will pick up their medication at the inland compounding pharmacy and will be instructed to use the nasal spray- 2 sprays twice a day for 6 weeks.
  5. After 6 weeks the subjects will return to the office for repeat nasal endoscopy and will be asked to fill out a SNOT 20 survey.
  6. Continued therapy of the nasal steroid spray will be at the discretion of the physician. If subjects do not appear to be responding the nasal steroid spray the medication will be altered as deemed medically necessary.
  Eligibility

Ages Eligible for Study:   17 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group 1 - will be given fluticasone nasal spray Group 2- will be given dexamethasone nasal spray The 2 groups will be compared in terms of symptom control and polyp size

Criteria

Inclusion Criteria:

  • Subjects with nasal polyps who have had sinus surgery at least 3 months prior to enrollment.

Exclusion Criteria:

  • Allergy to steroids
  • Glaucoma
  • Cataracts
  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: NCT01777906

Contacts
Contact: Kristin Seiberling 909 553 5326 kseiberling@llu.edu

Locations
United States, California
Sinus and Allergy Center Recruiting
Loma Linda, California, United States, 92373
Contact: Kristin A Seiberling, MD    909-553-5326    kseiberling@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Kristin Seiberling, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Kristin Seiberling, MD, Principil investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01777906     History of Changes
Other Study ID Numbers: 060476
Study First Received: January 24, 2013
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
nasal polyps
nasal steriod sprays

Additional relevant MeSH terms:
Polyps
Nasal Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014