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

NCT ID: NCT01777906

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-02-28

Brief 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.

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.

Conditions

Size of Nasal Polyps; Control of Symptoms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fluticasone

Fluticasone nasal spray will be given 2 sprays twice a day for 6 weeks.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Seiberling, MD

Principil investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Sinus and Allergy Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

5130043

Identifier Type: -

Identifier Source: org_study_id