N/A
N=37
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
Chronic Sinusitis · Nasal Polyposis
Bottom Line
View on ClinicalTrials.gov: NCT02562924 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Lund-Kennedy Endoscopic Scores — -8.0; -1.5; -6.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MEDIHONEY® (Device); Budesonide (Drug); Normal saline sinus rinse (Drug); Prednisone (Drug); Endoscopic sinus surgery (Procedure); nasal saline spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont Medical Center
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lund-Kennedy Endoscopic Scores |
-8.0; -1.5; -6.9 | — |
| SECONDARY Nasal Drainage Cultures |
— | — |
| SECONDARY Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score |
-22.8; -15.3; -25.6 | — |
| SECONDARY Change in SNOT-22 Nasal Symptom Scores |
-10.0; -5.3; -11.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02562924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.