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
: January 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Sinusitis | Drug: Xylitol Drug: Saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 2009 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

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 Name: Salt solution
|
- SNOT-20 Scores at 12 Weeks [ 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.
- Antibiotic Use [ Time Frame: 12 weeks ]Number of antibiotic courses for infections during the study period

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

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
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Lakshmi Durairaj, M.D. | University of Iowa |
Responsible Party: | Lakshmi Durairaj, Assistant Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT00924404 History of Changes |
Other Study ID Numbers: |
200903757 |
First Posted: | June 19, 2009 Key Record Dates |
Results First Posted: | August 9, 2017 |
Last Update Posted: | January 2, 2018 |
Last Verified: | December 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 |