Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- SNOT-20 Scores at 12 Weeks
研究概览
简要总结
Is a xylitol nasal rinse better or worse than saline on patient satisfaction.
详细描述
In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol nasal rinse with saline rinse which is the current standard, on outcomes such as quality of life and exacerbations.
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
- 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
- •56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:
- •Anterior and/or posterior mucopurulent drainage
- •Nasal obstruction
- •Facial pain, pressure, and/or fullness
- •Decreased sense of smell
- •In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
排除标准
- •Cystic fibrosis
- •Fungal sinusitis
- •Immunocompromised status (use of long term oral steroids (> 30 days), AIDS, active malignancy or chemotherapy)
- •Known Ciliary disorders
- •Sinonasal tumors
- •Pregnancy
- •Group 2: CRS with antibody deficiency
- •56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:
- •Anterior and/or posterior mucopurulent drainage
- •Nasal obstruction
- •Facial pain, pressure, and/or fullness
- •Decreased sense of smell
- •In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
- •Exclusion criteria:
- •Cystic Fibrosis Sinonasal tumors Pregnancy
研究组 & 干预措施
Xylitol
isotonic xylitol for sinus rinse
干预措施: Xylitol (Drug)
Saline
saline for sinus rinse
干预措施: Saline (Drug)
结局指标
主要结局
SNOT-20 Scores at 12 Weeks
时间窗: 12 weeks
Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues. Symptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent "as troublesome as possible". The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100.
次要结局
- Mean Number of Antibiotic Courses During the Study Period(12 weeks)
研究者
Lakshmi Durairaj
Assistant Professor
University of Iowa