Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps
Condition: Size of Nasal Polyps; Control of Symptoms
MeSH terms: Nasal Polyps; Polyps
Study type: Observational

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.
    

Observational model: Cohort
Time perspective: Prospective
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
      
Keywords: nasal polyps; nasal steriod sprays