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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Vermont Medical Center
Sponsor:
Information provided by (Responsible Party):
Gary Landrigan, MD, University of Vermont Medical Center
ClinicalTrials.gov Identifier:
NCT02562924
First received: April 21, 2015
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Chronic Sinusitis
Nasal Polyposis
Device: MEDIHONEY®
Drug: Budesonide
Drug: Normal saline sinus rinse
Drug: Prednisone
Procedure: Endoscopic sinus surgery
Drug: nasal saline spray

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Vermont Medical Center:

Primary Outcome Measures:
  • Lund-Kennedy endoscopic scores [ Time Frame: 6 months ]
    Characteristics are assessed endoscopically of each sinonasal cavity to provide a score - polyp disease, mucosal edema/crusting/scarring and nasal secretion each receiving a score from 0 to 2. This scoring system has since been the instrument of choice to endoscopically evaluate outcomes of interventions in non-neoplastic sinonasal disease prospectively over time in research and clinical practice. Endoscopy scores from the 3 study groups will be compared for the average percent change between a patient's 6 scores at the 6 different study visits.


Secondary Outcome Measures:
  • Nasal drainage cultures [ Time Frame: 35 days ]
    Nasal drainage cultures from the 3 study groups will be compared for the average percent change between a patient's positive intraoperative cultures compared to the patient's cultures at day 35.

  • SNOT-22 questionnaire [ Time Frame: 6 months ]
    The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be). The overall score can theoretically range from 0 to 110, with higher scores reflecting more severe quality of life impairment as subjectively reported by the patient. Overall SNOT-22 scores from the 3 study groups will be compared for the average percent change between a patient's 6 scores at the 6 different study visits.

  • Symptom scores [ Time Frame: 6 months ]
    Total symptom scores from the 3 study groups will be compared for the average percent change between a patient's 6 scores at the 6 different study visits.


Estimated Enrollment: 36
Study Start Date: November 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 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.
Drug: Budesonide
Topical steroid
Drug: Normal saline sinus rinse
8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle
Drug: Prednisone
Post-operatively, 40 mg daily for 7 days
Procedure: Endoscopic sinus surgery
Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage
Drug: nasal saline spray
saline nasal mist every hour while awake
Experimental: 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.
Device: MEDIHONEY®
MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties
Drug: Normal saline sinus rinse
8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle
Drug: Prednisone
Post-operatively, 40 mg daily for 7 days
Procedure: Endoscopic sinus surgery
Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage
Drug: nasal saline spray
saline nasal mist every hour while awake
Experimental: 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.
Device: MEDIHONEY®
MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties
Drug: Budesonide
Topical steroid
Drug: Normal saline sinus rinse
8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle
Drug: Prednisone
Post-operatively, 40 mg daily for 7 days
Procedure: Endoscopic sinus surgery
Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage
Drug: nasal saline spray
saline nasal mist every hour while awake

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02562924

Contacts
Contact: Christine D Cairns, MD 8028474535 christine.dobrosky@gmail.com

Locations
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05403
Sponsors and Collaborators
University of Vermont Medical Center
Investigators
Principal Investigator: Gary P Landrigan, MD University of Vermont Medical Center
  More Information

Responsible Party: Gary Landrigan, MD, Associate Professor of Surgery, Division of Otolaryngology, Department of Surgery, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT02562924     History of Changes
Other Study ID Numbers: CHRMS 15-010
Study First Received: April 21, 2015
Last Updated: May 23, 2016

Keywords provided by University of Vermont Medical Center:
MEDIHONEY
Chronic Rhinosinusitis With Nasal Polyposis
Functional Endoscopic Sinus Surgery

Additional relevant MeSH terms:
Sinusitis
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Polyps
Pathological Conditions, Anatomical
Prednisone
Budesonide
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2017