Xylitol Versus Saline in Chronic Sinusitis
- Registration Number
- NCT00924404
- Lead Sponsor
- University of Iowa
- Brief Summary
Is a xylitol nasal rinse better or worse than saline on patient satisfaction.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Saline saline for sinus rinse Xylitol Xylitol isotonic xylitol for sinus rinse
- Primary Outcome Measures
Name Time Method SNOT-20 Scores at 12 Weeks 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.
- Secondary Outcome Measures
Name Time Method Mean Number of Antibiotic Courses During the Study Period 12 weeks Mean Number of antibiotic courses for infection during the study period
Trial Locations
- Locations (1)
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States