Xylitol Versus Saline in Chronic Sinusitis

Study Overview
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Brief Summary
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Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: Xylitol
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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We now have two arms to this study. Group I: Immunocompetent subjects with chronic rhinosinusitis Inclusion Criteria: 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. Exclusion Criteria: 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

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol<br>isotonic xylitol for sinus rinse | Drug: Xylitol<br>* 5% solution for sinus rinse<br>|
| Active Comparator: Saline<br>saline for sinus rinse | Drug: Saline<br>* saline for sinus rinse<br>* Other names: Salt solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-20 Scores at 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Antibiotic Courses During the Study Period | Mean Number of antibiotic courses for infection during the study period | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xylitol vs. Saline, nasal washes, sinusitis