Xylitol Versus Saline in Chronic Sinusitis

NCT ID: NCT00924404

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

Chronic Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Xylitol

isotonic xylitol for sinus rinse

Group Type: EXPERIMENTAL

Xylitol

Intervention Type: DRUG

5% solution for sinus rinse

Saline

saline for sinus rinse

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

saline for sinus rinse

Interventions

Xylitol

5% solution for sinus rinse

Intervention Type: DRUG

Saline

saline for sinus rinse

Intervention Type: DRUG

Other Intervention Names

Salt solution

Eligibility Criteria

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.

Cystic Fibrosis Sinonasal tumors Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Lakshmi Durairaj

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lakshmi Durairaj, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

200903757

Identifier Type: -

Identifier Source: org_study_id