Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps (dexamethasone)
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|ClinicalTrials.gov Identifier: NCT01777906|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : March 27, 2017
|Condition or disease|
|Size of Nasal Polyps Control of Symptoms|
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.
- 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
- Subjects will be asked to fill out a SNOT 20 survey before the start of therapy.
- 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.
- 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.
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Comparison of Topical Nasal Steroids in Postoperative Sinus Patients With Nasal Polyps|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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.
- Comparison of topical nasal steroids in postoperative sinus patients [ Time Frame: 1 year ]Primary outcome will be symptomatic improvement measured by the SNOT 20 survey and physical size of polyps as measured by nasal endoscopy.
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): NCT01777906
|United States, California|
|Sinus and Allergy Center|
|Loma Linda, California, United States, 92373|
|Principal Investigator:||Kristin Seiberling, MD||Loma Linda University|