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Xylitol Versus Saline in Chronic Sinusitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lakshmi Durairaj, University of Iowa
ClinicalTrials.gov Identifier:
NCT00924404
First received: June 18, 2009
Last updated: July 10, 2017
Last verified: May 2017
June 18, 2009
July 10, 2017
May 2009
August 2014   (Final data collection date for primary outcome measure)
SNOT-20 [ 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.

SNOT-20 [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00924404 on ClinicalTrials.gov Archive Site
Antibiotic Use [ Time Frame: 12 weeks ]
Number of antibiotic courses for infections during the study period
Antibiotic Use [ Time Frame: 12 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Single (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.
 
Completed
53
August 2014
August 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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00924404
200903757
No
Not Provided
Not Provided
Lakshmi Durairaj, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Lakshmi Durairaj, M.D. University of Iowa
University of Iowa
May 2017

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