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Xylitol Versus Saline in Chronic Sinusitis

Not Applicable
Completed
Conditions
Chronic Sinusitis
Interventions
Drug: Saline
Registration Number
NCT00924404
Lead Sponsor
University of Iowa
Brief Summary

Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
53
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SalineSalinesaline for sinus rinse
XylitolXylitolisotonic xylitol for sinus rinse
Primary Outcome Measures
NameTimeMethod
SNOT-20 Scores at 12 Weeks12 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
NameTimeMethod
Mean Number of Antibiotic Courses During the Study Period12 weeks

Mean Number of antibiotic courses for infection during the study period

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

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