N/A
N=53
Xylitol Versus Saline in Chronic Sinusitis
Chronic Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00924404 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: SNOT-20 Scores at 12 Weeks — 7; 11 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Xylitol (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SNOT-20 Scores at 12 Weeks |
7; 11 | — |
| SECONDARY Mean Number of Antibiotic Courses During the Study Period |
1.90; 1.77 | — |
Summary
Is a xylitol nasal rinse better or worse than saline on patient satisfaction.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00924404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.