Manuka Honey Sinus Rinse Study

Study Overview
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Brief Summary
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A trial investigating the effect of a sinus rinse in people with CF

Detailed Description
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People with with CF often have bacterial infection in their air ways. There is great interest in the different types of bacteria found within these infections. This clinical trial looks at whether a novel sinus rinse device (that incorporates manuka honey) could help clear infection or reduce the amount and/or types of bacteria found within the upper airway. This study assesses the changes in the Sino-Nasal Outcome Test (SNOT-22) scores along with any changes in quality of life, before and after the use of a sinus rinse device for 30 days. In addition to this, the amount and types of bacteria found in nasal swabs, the sinus rinse solution, and sputum samples, before and after using the sinus rinse device will be investigated. Sputum samples will also be monitored for changes in composition before and after using the sinus rinse.

Official Title
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A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients

Conditions
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Cystic Fibrosis, Infection, Bacterial

Intervention / Treatment
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* Device: Manuka honey sinus rinse
* Device: Standard sinus rinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is willing and able to give informed consent. The patient must be ≥ 18 years. The patient must have an established diagnosis of CF (one or more of the following) Sweat chloride >60mEq/L Presence of two CF causing mutations. The patient must have chronic symptoms of rhinosinusitis according to the criteria of the European Position Paper on Rhinosinusitis (appendix A). The patient scores greater ≥ 7 on their SNOT-22 questionnaire. Exclusion Criteria: The patient has ever tested positive for the bacteria Mycobacterium tuberculosis. The patient is currently using a nasal rinse protocol. The patient has undergone sinus surgery within 6 months. The patient suffers from nasal bleeding. The patient is currently undergoing systemic antibiotic therapy for infective exacerbation. The patient is using overnight oxygen via nasal cannula. The patient is participating in another clinical trial or has done so within the last 30 days. The patient has a known allergy to bee products. The patient has an objection to the use of bee products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Manuka honey sinus rinse | Device: Manuka honey sinus rinse<br>* Will follow a modified NHS nasal rinse protocol with the addition of manuka honey<br>|
| Active Comparator: Standard<br>Standard sinus rinse | Device: Standard sinus rinse<br>* will follow the standard NHS nasal rinse protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score | Does the addition of manuka honey to the sinus rinse change the Sino Nasal Outcome Test (SNOT)-22 score of patients with cystic fibrosis? The SNOT-22 scale runs from 0 -110 and a higher score indicating worse symptoms | Baseline and day 30 (+-7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score | Does the addition of manuka honey to a sinus rinse change the CFQ-R score in patients with cystic fibrosis? The scale runs from 1-100 and a higher score indicates a better outcome | Baseline and day 30 (+-7 days) | 
| Bacterial type and number | Does the addition of manuka honey to a sinus rinse impact on the bacterial type/amount found in the nasal/paranasal cavities of patients with cystic fibrosis | Baseline and day 30 (+-7 days) |