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Xylitol Versus Saline in Chronic Sinusitis

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xylitol
Saline
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring Xylitol vs. Saline, nasal washes, sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xylitol

Saline

Arm Description

isotonic xylitol for sinus rinse

saline for sinus rinse

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Number of Antibiotic Courses During the Study Period
Mean Number of antibiotic courses for infection during the study period

Full Information

First Posted
June 18, 2009
Last Updated
July 31, 2018
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT00924404
Brief Title
Xylitol Versus Saline in Chronic Sinusitis
Official Title
Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Xylitol vs. Saline, nasal washes, sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xylitol
Arm Type
Experimental
Arm Description
isotonic xylitol for sinus rinse
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
saline for sinus rinse
Intervention Type
Drug
Intervention Name(s)
Xylitol
Intervention Description
5% solution for sinus rinse
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Salt solution
Intervention Description
saline for sinus rinse
Primary Outcome Measure Information:
Title
SNOT-20 Scores at 12 Weeks
Description
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 Outcome Measure Information:
Title
Mean Number of Antibiotic Courses During the Study Period
Description
Mean Number of antibiotic courses for infection during the study period
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakshmi Durairaj, M.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Xylitol Versus Saline in Chronic Sinusitis

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