Xylitol Versus Saline in Chronic Sinusitis

Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis

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

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Drug: Xylitol; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Salt solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOT-20 Scores at 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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Antibiotic Courses During the Study Period	Mean Number of antibiotic courses for infection during the study period	12 weeks

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Lakshmi Durairaj, M.D., University of Iowa

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: sinusitis; Xylitol vs. Saline; nasal washes
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease
• Other Study ID Numbers: 200903757