Trial Outcomes & Findings for The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery (NCT NCT02562924)
NCT ID: NCT02562924
Last Updated: 2019-10-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
119 days
Results posted on
2019-10-16
Participant Flow
All subjects were enrolled prior to surgery (day 0). Days 0-7 all subjects were treated with oral prednisone once daily, nasal saline irrigation four times daily, and nasal saline misting hourly while awake. Assignment to each arm occurred on day 7. Three enrolled subjects withdrew prior to assignment because they elected to not undergo surgery.
Participant milestones
| Measure |
Budesonide Rinse Group
1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly 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.
Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: 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 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 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 until day 182
2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182
MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
1
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
11
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
Baseline characteristics by cohort
| Measure |
Budesonide Rinse Group
n=13 Participants
1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly 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.
Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake
|
MEDIHONEY® Rinse Alone Group
n=12 Participants
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 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 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 until day 182
2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182
MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties
|
MEDIHONEY® and Budesonide Rinse Group
n=12 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 19 • n=99 Participants
|
51 years
STANDARD_DEVIATION 14 • n=107 Participants
|
58 years
STANDARD_DEVIATION 8 • n=206 Participants
|
56 years
STANDARD_DEVIATION 14 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
37 participants
n=7 Participants
|
|
Current Smoker
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Former Smoker
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
History of Asthma
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
History of Diabetes
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
History of Environmental Allergies
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
History of Bronchiectasis
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Lund-Mackay Radiographic Score
|
15.8 units on a scale
STANDARD_DEVIATION 6.6 • n=99 Participants
|
14.8 units on a scale
STANDARD_DEVIATION 5.6 • n=107 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 5.2 • n=206 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
|
Baseline Surgery Score
|
12.8 units on a scale
STANDARD_DEVIATION 1.0 • n=99 Participants
|
13.0 units on a scale
STANDARD_DEVIATION 1.0 • n=107 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 0.9 • n=206 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
PRIMARY outcome
Timeframe: 119 daysPopulation: The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).
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.
Outcome measures
| Measure |
Budesonide Rinse Group
n=11 Participants
1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly 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.
Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake
|
MEDIHONEY® Rinse Alone Group
n=6 Participants
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 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 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 until day 182
2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182
MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties
|
MEDIHONEY® and Budesonide Rinse Group
n=9 Participants
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.
|
|---|---|---|---|
|
Change in Lund-Kennedy Endoscopic Scores
|
-8.0 score on a scale
Standard Deviation 3.1
|
-1.5 score on a scale
Standard Deviation 4.6
|
-6.9 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 35 daysPopulation: This secondary objective describes analyzing quantitative changes in microbiology between day of surgery and post-operative day 35. These data were not collected, but rather the qualitative data (which microorganisms were present) were. Therefore we are not able to complete analysis on this secondary objective.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 119 daysPopulation: The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).
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.
Outcome measures
| Measure |
Budesonide Rinse Group
n=11 Participants
1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly 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.
Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake
|
MEDIHONEY® Rinse Alone Group
n=6 Participants
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 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 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 until day 182
2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182
MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties
|
MEDIHONEY® and Budesonide Rinse Group
n=9 Participants
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.
|
|---|---|---|---|
|
Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score
|
-22.8 score on a scale
Standard Deviation 20.2
|
-15.3 score on a scale
Standard Deviation 27.4
|
-25.6 score on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 119 daysPopulation: The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).
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.
Outcome measures
| Measure |
Budesonide Rinse Group
n=11 Participants
1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly 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.
Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake
|
MEDIHONEY® Rinse Alone Group
n=6 Participants
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 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 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 until day 182
2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182
MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties
|
MEDIHONEY® and Budesonide Rinse Group
n=9 Participants
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.
|
|---|---|---|---|
|
Change in SNOT-22 Nasal Symptom Scores
|
-10.0 score on a scale
Standard Deviation 7.0
|
-5.3 score on a scale
Standard Deviation 15.5
|
-11.7 score on a scale
Standard Deviation 7.9
|
Adverse Events
Budesonide Rinse Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MEDIHONEY® Rinse Alone Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
MEDIHONEY® and Budesonide Rinse Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Budesonide Rinse Group
n=13 participants at risk
1a. Days 0-7: 40 mg prednisone daily, saline sinus rinse 4 times daily, nasal saline spray hourly 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.
Budesonide: Topical steroid Normal saline sinus rinse: 8 oz or 4 oz normal saline with NeilMed sinus rinse bottle Prednisone: Post-operatively 40 mg daily for 7 days Endoscopic sinus surgery: Surgery to debride polyps and establish adequate sinus drainage Nasal saline spray: saline nasal mist every hour while awake
|
MEDIHONEY® Rinse Alone Group
n=12 participants at risk
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 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 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 until day 182
2. In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182
MEDIHONEY®: A seminatural product with antibacterial and anti-inflammatory properties
|
MEDIHONEY® and Budesonide Rinse Group
n=12 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Nasal Pain
|
7.7%
1/13 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Eye disorders
Blurred Vision
|
7.7%
1/13 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Psychiatric disorders
Mood alteration (anxiety)
|
7.7%
1/13 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • 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.
|
8.3%
1/12 • 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.
|
0.00%
0/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/13 • 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.
|
8.3%
1/12 • 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.
|
0.00%
0/12 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place