The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
Completed · Not applicable
Conditions studied: Chronic Sinusitis, Nasal Polyposis
In brief
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.
Key facts
- Study ID
- NCT02562924
- Run by
- University of Vermont Medical Center
- People needed
- 40
- Starts
- 2015-11-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older;
- 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:
- 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
- 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.
You may not qualify if…
- Contraindications to oral prednisone or known hypersensitivity to any study medications;
- Churg Strauss disorder;
- abnormalities of mucociliary clearance (cystic fibrosis, primary ciliary dyskinesia and Young's syndrome);
- Diagnosed immunodeficiency;
- Aspirin-induced asthma (ASA) (aka Samter triad) (a triad of asthma, aspirin and NSAID sensitivity, and nasal/ethmoidal polyposis).
Where it is running
- University of Vermont Medical Center — Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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