Xylitol Versus Saline in Chronic Sinusitis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2014 by University of Iowa.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Lakshmi Durairaj, University of Iowa

ClinicalTrials.gov Identifier:

NCT00924404

First received: June 18, 2009

Last updated: May 20, 2014

Last verified: May 2014

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 University of Iowa:

Primary Outcome Measures:

SNOT-20 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

antibiotic use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	56
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	July 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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924404

Locations


United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Janice L Launspach, R.N., CCRC 319-356-2047 janice-launspach@uiowa.edu
Contact: Lakshmi Durairaj, M.D. 319-353-7968 lakshmi-durairaj@uiowa.edu
Principal Investigator: Lakshmi Durairaj, M.D.

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:	IRB Protocol #200903757
Study First Received:	June 18, 2009
Last Updated:	May 20, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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