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Xylitol Versus Saline in Chronic Sinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Iowa
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

June 18, 2009
May 20, 2014
May 2009
July 2014   (final data collection date for primary outcome measure)
SNOT-20 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00924404 on ClinicalTrials.gov Archive Site
antibiotic use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Xylitol Versus Saline in Chronic Sinusitis
Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Sinusitis
  • Drug: Xylitol
    5% solution for sinus rinse
  • Drug: Saline
    saline for sinus rinse
    Other Name: Salt solution
  • Experimental: Xylitol
    isotonic xylitol for sinus rinse
    Intervention: Drug: Xylitol
  • Active Comparator: Saline
    saline for sinus rinse
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
January 2015
July 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
United States
 
NCT00924404
IRB Protocol #200903757
No
Lakshmi Durairaj, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Lakshmi Durairaj, M.D. University of Iowa
University of Iowa
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP