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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Lund-Kennedy Endoscopic Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- •Age 18 years or older;
- •Diagnosis of CRSwNP based on the following criteria:
- •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:
- •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.
排除标准
- •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).
研究组 & 干预措施
Budesonide rinse group
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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Budesonide (Drug)
Budesonide rinse group
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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Normal saline sinus rinse (Drug)
Budesonide rinse group
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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Prednisone (Drug)
Budesonide rinse group
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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Endoscopic sinus surgery (Procedure)
Budesonide rinse group
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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: nasal saline spray (Drug)
MEDIHONEY® rinse alone group
- Days 0-7: Same as 1a;
- Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: MEDIHONEY® (Device)
MEDIHONEY® rinse alone group
- Days 0-7: Same as 1a;
- Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Normal saline sinus rinse (Drug)
MEDIHONEY® rinse alone group
- Days 0-7: Same as 1a;
- Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Prednisone (Drug)
MEDIHONEY® rinse alone group
- Days 0-7: Same as 1a;
- Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: Endoscopic sinus surgery (Procedure)
MEDIHONEY® rinse alone group
- Days 0-7: Same as 1a;
- Days 7-91: 8oz saline sinus rinse followed with 0.5oz of MEDIHONEY® in 50 cc of normal saline.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 1.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 1.c.ii till day 182.
干预措施: nasal saline spray (Drug)
MEDIHONEY® and budesonide rinse group
- Days 0-7: Same as 1a.;
- Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.
干预措施: MEDIHONEY® (Device)
MEDIHONEY® and budesonide rinse group
- Days 0-7: Same as 1a.;
- Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.
干预措施: Budesonide (Drug)
MEDIHONEY® and budesonide rinse group
- Days 0-7: Same as 1a.;
- Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.
干预措施: Normal saline sinus rinse (Drug)
MEDIHONEY® and budesonide rinse group
- Days 0-7: Same as 1a.;
- Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.
干预措施: Prednisone (Drug)
MEDIHONEY® and budesonide rinse group
- Days 0-7: Same as 1a.;
- Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.
干预措施: Endoscopic sinus surgery (Procedure)
MEDIHONEY® and budesonide rinse group
- Days 0-7: Same as 1a.;
- Days 7-91: 8oz saline/budesonide sinus rinse followed by 0.5oz of MEDIHONEY® in 50 cc of normal saline BID.
- 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:
- In case endoscopy shows any polyps, edema or discharge: Return to the initial regimen as per 3.c.i till day 182.
- In case endoscopy shows no polyps, edema and discharge: Continue as per 3.c.ii till day 182.
干预措施: nasal saline spray (Drug)
结局指标
主要结局
Change in Lund-Kennedy Endoscopic Scores
时间窗: 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.
次要结局
- Nasal Drainage Cultures(35 days)
- Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score(119 days)
- Change in SNOT-22 Nasal Symptom Scores(119 days)
研究者
Gary Landrigan, MD
Associate Professor of Surgery, Division of Otolaryngology, Department of Surgery
University of Vermont Medical Center