Xylitol Versus Saline in Chronic Sinusitis

NCT00924404 | Completed Results

• 1 other identifier: 200903757
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Sinusitis

Keywords

Xylitol vs. Saline; nasal washes; sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Number of Antibiotic Courses During the Study Period

  12 weeks

Study Arms (2)

Xylitol

EXPERIMENTAL

isotonic xylitol for sinus rinse

Drug: Xylitol

Saline

ACTIVE COMPARATOR

saline for sinus rinse

Drug: Saline

Interventions

Xylitol DRUG

5% solution for sinus rinse

Xylitol

Saline DRUG

saline for sinus rinse

Also known as: Salt solution

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Cystic Fibrosis Sinonasal tumors Pregnancy

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Xylitol; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Lakshmi Durairaj
• Organization: University of Iowa

lakshmi-durairaj@uiowa.edu

319-353-7968

Study Officials

• Lakshmi Durairaj, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 31, 2018
• Results First Posted: August 9, 2017

Record last verified: 2018-07

Locations

US (1)