Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps

Control of Symptoms Clinical Trial

— dexamethasone  

Official title:

Comparison of Topical Nasal Steroids in Postoperative Sinus Patients With Nasal Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777906
• Other study ID #: 5130043
• Status: Completed
• Phase: N/A
• First received: January 24, 2013
• Last updated: March 24, 2017
• Start date: February 2013
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Control of Symptoms
• Nasal Polyps
• Polyps
• Size of Nasal Polyps

Locations

Country	Name	City	State
United States	Sinus and Allergy Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of topical nasal steroids in postoperative sinus patients	Primary outcome will be symptomatic improvement measured by the SNOT 20 survey and physical size of polyps as measured by nasal endoscopy.	1 year