Xylitol Versus Saline in Chronic Sinusitis

Chronic Sinusitis Clinical Trial

Official title:

Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924404
• Other study ID #: 200903757
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: August 2014

Study information

• Verified date: July 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• Xylitol
5% solution for sinus rinse
• Saline
saline for sinus rinse

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Number of Antibiotic Courses During the Study Period	Mean Number of antibiotic courses for infection during the study period	12 weeks