Clinical trial NCT02562924: The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
Official title: An Open-label, Prospective, Randomized, Pilot Clinical Study to Study the Efficacy of MEDIHONEY® Rinses Compared to Intranasal Corticosteroid Rinses in Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Nasal Polyposis
Keywords: MEDIHONEY
Chronic Rhinosinusitis With Nasal Polyposis
Functional Endoscopic Sinus Surgery
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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).

Primary outcomes:
measure: Change in Lund-Kennedy Endoscopic Scores
timeFrame: 119 days
Secondary outcomes:
measure: Nasal Drainage Cultures
timeFrame: 35 days
measure: Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score
timeFrame: 119 days
measure: Change in SNOT-22 Nasal Symptom Scores
timeFrame: 119 days
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Vermont Medical Center
name: Gary P Landrigan, MD
role: PRINCIPAL_INVESTIGATOR
References: