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Xylitol Versus Saline in Chronic Sinusitis

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ClinicalTrials.gov Identifier: NCT00924404
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : August 9, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Lakshmi Durairaj, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Sinusitis
Interventions Drug: Xylitol
Drug: Saline
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Xylitol Saline
Hide Arm/Group Description

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

saline for sinus rinse

Saline: saline for sinus rinse

Period Title: Overall Study
Started 27 26
Completed 21 22
Not Completed 6 4
Reason Not Completed
Lost to Follow-up             6             4
Arm/Group Title Xylitol Saline Total
Hide Arm/Group Description

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

saline for sinus rinse

Saline: saline for sinus rinse

Total of all reporting groups
Overall Number of Baseline Participants 27 26 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 26 participants 53 participants
51  (14) 55  (17) 54  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Female
17
  63.0%
20
  76.9%
37
  69.8%
Male
10
  37.0%
6
  23.1%
16
  30.2%
1.Primary Outcome
Title SNOT-20 Scores at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
We initially enrolled 53 subjects but we had 10 subjects drop out of the study.
Arm/Group Title Xylitol Saline
Hide Arm/Group Description:

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

saline for sinus rinse

Saline: saline for sinus rinse

Overall Number of Participants Analyzed 21 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
7  (15) 11  (16)
2.Secondary Outcome
Title Mean Number of Antibiotic Courses During the Study Period
Hide Description Mean Number of antibiotic courses for infection during the study period
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xylitol Saline
Hide Arm/Group Description:

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

saline for sinus rinse

Saline: saline for sinus rinse

Overall Number of Participants Analyzed 21 22
Mean (Standard Deviation)
Unit of Measure: mean number of antibiotic courses during
1.90  (0.30) 1.77  (0.43)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Xylitol Saline
Hide Arm/Group Description

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

saline for sinus rinse

Saline: saline for sinus rinse

All-Cause Mortality
Xylitol Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Xylitol Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Xylitol Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lakshmi Durairaj
Organization: University of Iowa
Phone: 319-353-7968
EMail: lakshmi-durairaj@uiowa.edu
Layout table for additonal information
Responsible Party: Lakshmi Durairaj, University of Iowa
ClinicalTrials.gov Identifier: NCT00924404    
Other Study ID Numbers: 200903757
First Submitted: June 18, 2009
First Posted: June 19, 2009
Results First Submitted: May 31, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 31, 2018