A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score
研究概览
简要总结
A trial investigating the effect of a sinus rinse in people with CF
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score
时间窗: Baseline and day 30 (+-7 days)
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
次要结局
- Bacterial type and number(Baseline and day 30 (+-7 days))
- Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score(Baseline and day 30 (+-7 days))