NCT02562924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 16, 2019

Completed
Last Updated

October 16, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

April 21, 2015

Results QC Date

April 18, 2019

Last Update Submit

September 27, 2019

Conditions

Chronic SinusitisNasal Polyposis

Keywords

MEDIHONEYChronic Rhinosinusitis With Nasal PolyposisFunctional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

  • Change in Lund-Kennedy Endoscopic Scores

    Characteristics of each sinonasal cavity are assessed endoscopically to provide a score based on polyp disease, mucosal edema/crusting/scarring and nasal secretions. A score is provided for the left and right. The scores are totaled to provide a number between 0 and 20. Polyps: 0 = absence of polyp; 1 = polyps in middle meatus only; 2 = polyps beyond middle meatus Edema: 0 = absent; 1 = mild; 2 = severe Discharge: 0 = no discharge; 1 = clear, thin discharge; 2 = thick, purulent discharge Scarring: 0 = absent; 1 = mild; 2 = severe Crusting: 0 = absent; 1 = mild; 2 = severe 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. The higher the score, the worse the outcome. Endoscopy scores from the 3 study groups are compared for the average unit change between baseline and day 119.

    119 days

Secondary Outcomes (3)

  • Nasal Drainage Cultures

    35 days

  • Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score

    119 days

  • Change in SNOT-22 Nasal Symptom Scores

    119 days

Study Arms (3)

Budesonide rinse group

ACTIVE COMPARATOR

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.

Drug: BudesonideDrug: Normal saline sinus rinseDrug: PrednisoneProcedure: Endoscopic sinus surgeryDrug: nasal saline spray

MEDIHONEY® rinse alone group

EXPERIMENTAL

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®Drug: Normal saline sinus rinseDrug: PrednisoneProcedure: Endoscopic sinus surgeryDrug: nasal saline spray

MEDIHONEY® and budesonide rinse group

EXPERIMENTAL

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®Drug: BudesonideDrug: Normal saline sinus rinseDrug: PrednisoneProcedure: Endoscopic sinus surgeryDrug: nasal saline spray

Interventions

MEDIHONEY®DEVICE

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

MEDIHONEY® and budesonide rinse groupMEDIHONEY® rinse alone group
BudesonideDRUG

Topical steroid

Budesonide rinse groupMEDIHONEY® and budesonide rinse group
Normal saline sinus rinseDRUG

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

Budesonide rinse groupMEDIHONEY® and budesonide rinse groupMEDIHONEY® rinse alone group
PrednisoneDRUG

Post-operatively, 40 mg daily for 7 days

Budesonide rinse groupMEDIHONEY® and budesonide rinse groupMEDIHONEY® rinse alone group
Endoscopic sinus surgeryPROCEDURE

Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage

Budesonide rinse groupMEDIHONEY® and budesonide rinse groupMEDIHONEY® rinse alone group
nasal saline sprayDRUG

saline nasal mist every hour while awake

Budesonide rinse groupMEDIHONEY® and budesonide rinse groupMEDIHONEY® rinse alone group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05403, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

BudesonidePrednisone

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienes

Limitations and Caveats

Limitations of this study include: non-blinded study, high drop-out rate in one study arm, and lack of quantitative data for sinus cultures.

Results Point of Contact

Title
Dr. Daniel Gerges
Organization
University of Vermont Medical Center
daniel.gerges@uvmhealth.org
8028474535

Study Officials

  • Gary P Landrigan, MD

    University of Vermont Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery, Division of Otolaryngology, Department of Surgery

Study Record Dates

First Submitted

April 21, 2015

First Posted

September 29, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 16, 2019

Results First Posted

October 16, 2019

Record last verified: 2019-09

Locations

US(1)