The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery

In patients with refractory CRSwNP, functional endoscopic sinus surgery (FESS), is intended
to restore physiologic sinus ventilation and drainage, which can facilitate the gradual
resolution of mucosal disease. However, because FESS does not directly treat the underlying
inflammatory disorder, a successful sinus surgery must be followed by medical maintenance
therapy to control inflammatory processes.

The current mainstay of treatment of CRSwNP includes antibiotics and topical and systemic
steroids. There is evidence that administration of systemic steroids in the postoperative
period for patients who have polyps may have a significant impact on their postoperative
course. However, the chance of significant side effects increases with the dose and duration
of treatment and therefore the minimum dose necessary to control the disease should be given.
Antibiotics also have their limited but documented side effects and can induce resistance.

A semi-natural product like manuka honey (brand name MEDIHONEY®), with antibacterial and
anti-inflammatory properties, might prove as a useful alternative since it has no major
adverse events documented in the literature, does not induce resistance and is effective
against resistant pathogens common in this patient population.

This study is a prospective, randomized, pilot clinical trial that will determine if the use
of MEDIHONEY® sinus rinses (alone or in combination with intranasal steroids) in the
postoperative period enhances recovery and prevents polyp recurrence in patients after
functional endoscopic sinus surgery (FESS), compared with the standard regimen of topical
corticosteroid sinus rinses. The study will collect and compare subjective and objective
efficacy assessments of both types of rinses.

Inclusion Criteria:

1. Age 18 years or older;

2. Diagnosis of CRSwNP based on the following criteria:

- Pattern of symptoms:

i. Symptoms present for ≥12 wk

- Symptoms for diagnosis: Requires ≥2 of the following symptoms:

i. Anterior and/or posterior mucopurulent drainage; ii. Nasal obstruction; iii. Facial
pain/pressure/fullness;

- Objective documentation: Requires both:

1. Endoscopy to verify the presence of polyps in middle meatus and document presence
of inflammation, such as discolored mucus or edema of middle meatus or ethmoid
area; and

2. Evidence of rhinosinusitis on imaging by CT (1 obvious polypoid tissue or sinus
opacification and/or at least 2mm of mucosal thickening).

- Failed medical management (i.e. refractory CRSwNP) and eligible for FESS.

Exclusion Criteria:

1. Contraindications to oral prednisone or known hypersensitivity to any study
medications;

2. Churg Strauss disorder;

3. abnormalities of mucociliary clearance (cystic fibrosis, primary ciliary dyskinesia
and Young's syndrome);

4. Diagnosed immunodeficiency;

5. Aspirin-induced asthma (ASA) (aka Samter triad) (a triad of asthma, aspirin and NSAID
sensitivity, and nasal/ethmoidal polyposis).