Xylitol Versus Saline in Chronic Sinusitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00924404
First received: June 18, 2009
Last updated: May 16, 2011
Last verified: May 2011
  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:


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: September 2012
Estimated Primary Completion Date: September 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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
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

No publications provided

Responsible Party: Lakshmi Durairaj, M.D., 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 16, 2011
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 which is 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 April 22, 2014