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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
Sponsor:
Information provided by (Responsible Party):
Lakshmi Durairaj, University of Iowa

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Sinusitis Drug: Xylitol Drug: Saline Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Xylitol
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Antibiotic Use [ Time Frame: 12 weeks ]
    Number of antibiotic courses for infections during the study period


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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