Trial Outcomes & Findings for Xylitol Versus Saline in Chronic Sinusitis (NCT NCT00924404)

NCT ID: NCT00924404

Last Updated: 2018-08-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-08-31

Participant Flow

Participant milestones

Measure	Xylitol isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	Saline saline for sinus rinse Saline: saline for sinus rinse
Overall Study STARTED	27	26
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	Xylitol isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	Saline saline for sinus rinse Saline: saline for sinus rinse
Overall Study Lost to Follow-up	6	4

Baseline Characteristics

Xylitol Versus Saline in Chronic Sinusitis

Baseline characteristics by cohort

Measure	Xylitol n=27 Participants isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	Saline n=26 Participants saline for sinus rinse Saline: saline for sinus rinse	Total n=53 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 14 • n=5 Participants	55 years STANDARD_DEVIATION 17 • n=7 Participants	54 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: We initially enrolled 53 subjects but we had 10 subjects drop out of the study.

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.

Outcome measures

Measure	Xylitol n=21 Participants isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	Saline n=22 Participants saline for sinus rinse Saline: saline for sinus rinse
SNOT-20 Scores at 12 Weeks	7 units on a scale Standard Deviation 15	11 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 12 weeks

Mean Number of antibiotic courses for infection during the study period

Outcome measures

Measure	Xylitol n=21 Participants isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	Saline n=22 Participants saline for sinus rinse Saline: saline for sinus rinse
Mean Number of Antibiotic Courses During the Study Period	1.90 mean number of antibiotic courses during Standard Deviation 0.30	1.77 mean number of antibiotic courses during Standard Deviation 0.43

Adverse Events

Xylitol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lakshmi Durairaj

University of Iowa

Phone: 319-353-7968

Email: lakshmi-durairaj@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place