Chronic SinusitisNCT02562924
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
A study testing MEDIHONEY®, Budesonide and Normal saline sinus rinse in people with Chronic Sinusitis and Nasal Polyposis, run by University of Vermont Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Nasal Polyposis
- What is being tested?
- MEDIHONEY®, Budesonide and Normal saline sinus rinse
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18 years or older;
- 2. Diagnosis of CRSwNP based on the following criteria:
- Pattern of symptoms:
- Symptoms present for ≥12 wk
- Symptoms for diagnosis: Requires ≥2 of the following symptoms:
- Anterior and/or posterior mucopurulent drainage; ii. Nasal obstruction; iii. Facial pain/pressure/fullness;
Show all 10Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05403
About this study
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
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.
Read the 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
- Being tested
- MEDIHONEY®, Budesonide, Normal saline sinus rinse, Prednisone, Endoscopic sinus surgery
- Keywords
- MEDIHONEY, Chronic Rhinosinusitis With Nasal Polyposis, Functional Endoscopic Sinus Surgery
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDIHONEY®Device
MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties
BudesonideDrug
Topical steroid
Normal saline sinus rinseDrug
8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle
PrednisoneDrug
Post-operatively, 40 mg daily for 7 days
Endoscopic sinus surgeryProcedure or surgery
Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage
nasal saline sprayDrug
saline nasal mist every hour while awake
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Budesonide; Drug: Normal saline sinus rinse; Drug: Prednisone; Procedure: Endoscopic sinus surgery; Drug: 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. Receives: Device: MEDIHONEY®; Drug: Normal saline sinus rinse; Drug: Prednisone; Procedure: Endoscopic sinus surgery; Drug: 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. Receives: Device: MEDIHONEY®; Drug: Budesonide; Drug: Normal saline sinus rinse; Drug: Prednisone; Procedure: Endoscopic sinus surgery; Drug: nasal saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 119 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 119 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Landrigan, MD, University of Vermont Medical Center
- Investigators
- Gary P Landrigan, MD, Principal investigator, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562924
- Sponsor's protocol ID
- CHRMS 15-010
- Status last verified
- Sep 2019
- First submitted
- 21 Apr 2015
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02562924
- Acronym / sponsor ID
- CHRMS 15-010
- Conditions
- Chronic Sinusitis, Nasal Polyposis
- Keywords
- MEDIHONEY, Chronic Rhinosinusitis With Nasal Polyposis, Functional Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Posted 16 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Budesonide rinse group | Active comparator | Drug: Budesonide, Drug: Normal saline sinus rinse, Drug: Prednisone, Procedure: Endoscopic sinus surgery, Drug: nasal saline spray1a. 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. |
| MEDIHONEY® rinse alone group | Experimental | Device: MEDIHONEY®, Drug: Normal saline sinus rinse, Drug: Prednisone, Procedure: Endoscopic sinus surgery, Drug: nasal saline spray1. 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. |
| MEDIHONEY® and budesonide rinse group | Experimental | Device: MEDIHONEY®, Drug: Budesonide, Drug: Normal saline sinus rinse, Drug: Prednisone, Procedure: Endoscopic sinus surgery, Drug: nasal saline spray1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Age 18 years or older;
- Pattern of symptoms:
- Symptoms for diagnosis: Requires ≥2 of the following symptoms:
- Objective documentation: Requires both:
- Failed medical management (i.e. refractory CRSwNP) and eligible for FESS.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDIHONEY®MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties | Device | MEDIHONEY® and budesonide rinse group, MEDIHONEY® rinse alone group |
| BudesonideTopical steroid | Drug | Budesonide rinse group, MEDIHONEY® and budesonide rinse group |
| Normal saline sinus rinse8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle | Drug | Budesonide rinse group, MEDIHONEY® and budesonide rinse group, MEDIHONEY® rinse alone group |
| PrednisonePost-operatively, 40 mg daily for 7 days | Drug | Budesonide rinse group, MEDIHONEY® and budesonide rinse group, MEDIHONEY® rinse alone group |
| Endoscopic sinus surgeryEndoscopic sinus surgery to debride polyps and establish adequate sinus drainage | Procedure or surgery | Budesonide rinse group, MEDIHONEY® and budesonide rinse group, MEDIHONEY® rinse alone group |
| nasal saline spraysaline nasal mist every hour while awake | Drug | Budesonide rinse group, MEDIHONEY® and budesonide rinse group, MEDIHONEY® rinse alone group |
Primary outcome
Change in Lund-Kennedy Endoscopic Scores
Time frame: 119 days
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.
3 secondary outcomes
Nasal Drainage Cultures
Time frame: 35 days
Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score
Time frame: 119 days
Change in SNOT-22 Nasal Symptom Scores
Time frame: 119 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary P Landrigan, MD principal investigator
University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDIHONEY®, Budesonide and Normal saline sinus rinse in people with Chronic Sinusitis and Nasal Polyposis, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lund-Kennedy Endoscopic Scores (time frame: 119 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.