Xylitol Versus Saline in Chronic Sinusitis

• Sponsor: University of Iowa (Other)
• Overall Status: Completed
• CT.gov ID: NCT00924404
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 2
• Duration (Months): 63
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinusitis	Drug: Xylitol; Drug: Saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xylitol isotonic xylitol for sinus rinse	Drug: Xylitol; 5% solution for sinus rinse
Active Comparator: Saline saline for sinus rinse	Drug: Saline; saline for sinus rinse; Other Names: Salt solution

Outcome Measures

Primary Outcome Measures

1. SNOT-20 Scores at 12 Weeks [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

1. Mean Number of Antibiotic Courses During the Study Period [12 weeks]

   Mean Number of antibiotic courses for infection during the study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa

Investigators

• Principal Investigator: Lakshmi Durairaj, M.D., University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lakshmi Durairaj, Assistant Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT00924404
• Other Study ID Numbers: 200903757
• First Posted: Jun 19, 2009
• Last Update Posted: Aug 31, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Lakshmi Durairaj, Assistant Professor, University of Iowa: Xylitol vs. Saline; nasal washes; sinusitis
• Additional relevant MeSH terms: Sinusitis; Chronic Disease

Study Results

Participant Flow

Arm/Group Title	Xylitol	Saline
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

Baseline Characteristics

Arm/Group Title	Xylitol	Saline	Total
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 Participants	27	26	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (14)	55 (17)	54 (16)
Sex: Female, Male (Count of Participants)
Female	17 63%	20 76.9%	37 69.8%
Male	10 37%	6 23.1%	16 30.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Xylitol	Saline
Arm/Group Description	isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	saline for sinus rinse Saline: saline for sinus rinse
Measure Participants	21	22
Mean (Standard Deviation) [units on a scale]	7 (15)	11 (16)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Xylitol	Saline
Arm/Group Description	isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse	saline for sinus rinse Saline: saline for sinus rinse
Measure Participants	21	22
Mean (Standard Deviation) [mean number of antibiotic courses during]	1.90 (0.30)	1.77 (0.43)

Adverse Events

Arm/Group Title	Xylitol		Saline
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Serious Adverse Events
	Xylitol		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Xylitol		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.