An interventional study of MEDIHONEY® and Budesonide in Chronic Sinusitis and Nasal Polyposis, sponsored by University of Vermont Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by University of Vermont Medical Center · Not applicable, Interventional, and Treatment
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.
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →University of Vermont Medical Center is the lead sponsor of 41 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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: Budesonide · Drug: Normal saline sinus rinse · Drug: Prednisone · Procedure: Endoscopic sinus surgery · Drug: nasal saline spray
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 rinse · Drug: Prednisone · Procedure: Endoscopic sinus surgery · Drug: nasal saline spray
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: Budesonide · Drug: Normal saline sinus rinse · Drug: Prednisone · Procedure: Endoscopic sinus surgery · Drug: nasal saline spray
MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties
Topical steroid
8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle
Post-operatively, 40 mg daily for 7 days
Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage
saline nasal mist every hour while awake
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.
Time frame: 119 days
Nasal Drainage Cultures
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.
Time frame: 35 days
Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score
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 are compared for the average change in score from baseline to day 119.
Time frame: 119 days
Change in SNOT-22 Nasal Symptom Scores
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 first seven questions relate to nasal symptoms. The nasal symptoms score is calculated by summing the scores for these first seven questions. The range is 0 to 35. Higher scores reflect more severe quality of life impairment as subjectively reported by the patient. The nasal symptom scores from the 3 study groups are compared for the average change in score from baseline to day 119.
Time frame: 119 days
| Milestone | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group |
|---|---|---|---|
| Started | 13 | 12 | 12 |
| Completed | 12 | 1 | 8 |
| Not completed | 1 | 11 | 4 |
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.
| score on a scale | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group |
|---|---|---|---|
| Change in Lund-Kennedy Endoscopic Scores | -8.0 ± 3.1 | -1.5 ± 4.6 | -6.9 ± 3.9 |
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.
No measurements were reported for this outcome.
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 are compared for the average change in score from baseline to day 119.
| score on a scale | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group |
|---|---|---|---|
| Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score | -22.8 ± 20.2 | -15.3 ± 27.4 | -25.6 ± 16.9 |
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 first seven questions relate to nasal symptoms. The nasal symptoms score is calculated by summing the scores for these first seven questions. The range is 0 to 35. Higher scores reflect more severe quality of life impairment as subjectively reported by the patient. The nasal symptom scores from the 3 study groups are compared for the average change in score from baseline to day 119.
| score on a scale | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group |
|---|---|---|---|
| Change in SNOT-22 Nasal Symptom Scores | -10.0 ± 7.0 | -5.3 ± 15.5 | -11.7 ± 7.9 |
Collected over Adverse event data was recorded in the form of a modified version of the Common Toxicity Criteria for Adverse Events (CTCAE). This was done at each visit from baseline (pre-surgery) to the 6th visit on day 182.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Budesonide Rinse Group | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| MEDIHONEY® Rinse Alone Group | 1/12 (8.3%) | 0/12 (0%) | 2/12 (16.7%) |
| MEDIHONEY® and Budesonide Rinse Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 0/13 | 1/12 | 0/12 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/13 | 1/12 | 0/12 |
| Nasal PainGeneral disorders | 1/13 | 0/12 | 0/12 |
| Blurred VisionEye disorders | 1/13 | 0/12 | 0/12 |
| Mood alteration (anxiety)Psychiatric disorders | 1/13 | 0/12 | 0/12 |
| Age, Continuous(years) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| Mean | 53 ± 19 | 51 ± 14 | 58 ± 8 | 56 ± 14 |
| Sex: Female, Male(Participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| Female | 2 | 4 | 1 | 7 |
| Male | 11 | 8 | 11 | 30 |
| Race (NIH/OMB)(Participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 13 | 12 | 12 | 37 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| United States | 13 | 12 | 12 | 37 |
| Current Smoker(Participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| Count of participants | 2 | 1 | 1 | 4 |
| Former Smoker(Participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| Count of participants | 5 | 4 | 4 | 13 |
| History of Asthma(Participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| Count of participants | 7 | 6 | 6 | 19 |
| History of Diabetes(Participants) | Budesonide Rinse Group | MEDIHONEY® Rinse Alone Group | MEDIHONEY® and Budesonide Rinse Group | Total |
|---|---|---|---|---|
| Count of participants | 2 | 0 | 0 | 2 |
4 further baseline measures are reported on the registry.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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