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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effectiveness of MEDIHONEY® sinus rinses (alone or in combination with intranasal corticosteroids) vs. intranasal corticosteroid sinus rinses on mucosal healing and polyp recurrence in the post-operative period following functional endoscopic sinus surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont Medical Center
• Treatments: Budesonide; Prednisone

Criteria

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).