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

University of Vermont Medical Center

Status: Completed

Conditions: Nasal Polyposis; Chronic Sinusitis

Treatments: Drug: nasal saline spray; Device: MEDIHONEY®; Procedure: Endoscopic sinus surgery; Drug: Budesonide; Drug: Normal saline sinus rinse; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02562924

CHRMS 15-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups

Budesonide rinse group

Active Comparator group

Description:

1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray q 1 hour while awake b. Days 7-91: 8oz saline/budesonide sinus rinse BID (twice daily) c. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse once daily. Reevaluate at day 119: 1. In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182. 2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.

Treatment:

Drug: nasal saline spray

Procedure: Endoscopic sinus surgery

Drug: Prednisone

Drug: Normal saline sinus rinse

Drug: Budesonide

MEDIHONEY® rinse alone group

Experimental group

Description:

1. Days 0-7: Same as 1a; 2. Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline. 3. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of the MEDIHONEY®rinse BID. Continue until day 182 ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz saline rinse followed with the 50cc of the MEDIHONEY®rinse once daily. Reevaluate at day 119: 1. In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182. 2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.

Treatment:

Device: MEDIHONEY®

Drug: nasal saline spray

Procedure: Endoscopic sinus surgery

Drug: Prednisone

Drug: Normal saline sinus rinse

MEDIHONEY® and budesonide rinse group

Experimental group

Description:

1. Days 0-7: Same as 1a.; 2. Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID. 3. After day 91: i. In case endoscopy shows any polyps, edema or discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse BID. Continue with this regimen till day 182. ii. In case endoscopy shows no polyps, edema and discharge: Decrease volume to 4 oz budesonide/saline rinse followed with 50cc of the MEDIHONEY® rinse once a day. Reevaluate at day 119: 1. In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182. 2. In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.

Treatment:

Device: MEDIHONEY®

Drug: nasal saline spray

Procedure: Endoscopic sinus surgery

Drug: Prednisone

Drug: Normal saline sinus rinse

Drug: Budesonide