Xylitol Versus Saline in Chronic Sinusitis

University of Iowa53 enrolled

Overview

Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Sinusitis

Interventions

XylitolDRUG

5% solution for sinus rinse

SalineDRUG

saline for sinus rinse

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

Mean Number of Antibiotic Courses During the Study Period

Mean Number of antibiotic courses for infection during the study period

Time frame: 12 weeks

Data from ClinicalTrials.gov

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