Xylitol Versus Saline in Chronic Sinusitis

University of Iowa

Status: Completed

Conditions: Chronic Sinusitis

Treatments: Drug: Xylitol; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00924404

200903757

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Xylitol

Experimental group

Description:

isotonic xylitol for sinus rinse

Treatment:

Drug: Xylitol

Saline

Active Comparator group

Description:

saline for sinus rinse

Treatment:

Drug: Saline