Xylitol Versus Saline in Chronic Sinusitis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00924404

First Posted: June 19, 2009

Last Update Posted: August 9, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Lakshmi Durairaj, University of Iowa

Purpose

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.

Condition	Intervention
Chronic Sinusitis	Drug: Xylitol Drug: Saline


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Xylitol

U.S. FDA Resources

Further study details as provided by Lakshmi Durairaj, University of Iowa:

Primary Outcome Measures:

SNOT-20 [ Time Frame: 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:

Antibiotic Use [ Time Frame: 12 weeks ]
Number of antibiotic courses for infections during the study period


Enrollment:	53
Study Start Date:	May 2009
Study Completion Date:	August 2014
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Salt solution

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924404

Locations


United States, Iowa
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

More Information


Responsible Party:	Lakshmi Durairaj, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier:	NCT00924404 History of Changes
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 9, 2017
Last Verified:	May 2017

Keywords provided by Lakshmi Durairaj, University of Iowa:


Xylitol sinusitis Comparing efficacy of twice daily xylitol nasal rinse with saline rinse presently current standard, comparing outcomes like quality of life and exacerbations

Additional relevant MeSH terms:


Sinusitis Chronic Disease Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases	Respiratory Tract Infections Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes

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