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

NCT ID: NCT02562924

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Chronic Sinusitis; Nasal Polyposis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Budesonide rinse group

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.

Group Type: ACTIVE_COMPARATOR

Budesonide

Intervention Type: DRUG

Topical steroid

Normal saline sinus rinse

Intervention Type: DRUG

8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle

Prednisone

Intervention Type: DRUG

Post-operatively, 40 mg daily for 7 days

Endoscopic sinus surgery

Intervention Type: PROCEDURE

Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage

nasal saline spray

Intervention Type: DRUG

saline nasal mist every hour while awake

MEDIHONEY® rinse alone group

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.

Group Type: EXPERIMENTAL

MEDIHONEY®

Intervention Type: DEVICE

MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties

Normal saline sinus rinse

Intervention Type: DRUG

8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle

Prednisone

Intervention Type: DRUG

Post-operatively, 40 mg daily for 7 days

Endoscopic sinus surgery

Intervention Type: PROCEDURE

Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage

nasal saline spray

Intervention Type: DRUG

saline nasal mist every hour while awake

MEDIHONEY® and budesonide rinse group

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.

Group Type: EXPERIMENTAL

MEDIHONEY®

Intervention Type: DEVICE

MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties

Budesonide

Intervention Type: DRUG

Topical steroid

Normal saline sinus rinse

Intervention Type: DRUG

8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle

Prednisone

Intervention Type: DRUG

Post-operatively, 40 mg daily for 7 days

Endoscopic sinus surgery

Intervention Type: PROCEDURE

Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage

nasal saline spray

Intervention Type: DRUG

saline nasal mist every hour while awake

Interventions

MEDIHONEY®

MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties

Intervention Type: DEVICE

Budesonide

Topical steroid

Intervention Type: DRUG

Normal saline sinus rinse

8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle

Intervention Type: DRUG

Prednisone

Post-operatively, 40 mg daily for 7 days

Intervention Type: DRUG

Endoscopic sinus surgery

Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage

Intervention Type: PROCEDURE

nasal saline spray

saline nasal mist every hour while awake

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gary Landrigan, MD

Associate Professor of Surgery, Division of Otolaryngology, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary P Landrigan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont Medical Center

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CHRMS 15-010

Identifier Type: -

Identifier Source: org_study_id