Xylitol/saline nasal irrigations in patients with CRS without polyps, a multicenter double-blind, randomized study in 66 subjects with CRS without polyps

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

1. Subjects must have a diagnosis of CRSsNP
2. Age * 18 and * 70 years.
3. Subjects must be willing to give Informed Consent and adhere to visit
schedules and medication restrictions.

Exclusion Criteria

1. Previous surgical procedures to the paranasal sinuses
2. A clear dental origin of the sinus disease
3. Systemic or local antibiotic treatment less than 1 month before, or during
the study.
4. Systemic steroid treatment less than 1 month before, or during the study.
5. Subjects administering homeopathica to nose or paranasal sinuses.
6. Nasal polyps.
7. Subjects in whom the infection can be explained by the following reasons:
a. Cystic fibrosis
b. Congenital mucociliary problems eg. Primary Ciliary Dyskinesia
8. Known systemic vasculitic and granulomatous disease.
9. AIDS or known to be HIV positive.
10. Smoking (in the past 6 months).
11. History of radiotherapy in head and neck region.
12. Severe anatomic abnormalities leading to an inability to administer the
irrigation solution to one side of the nose (for example a severe septal
deviation or a large bullous middle turbinate).
13. Craniofacial malformations.
14. Abnormalities requiring other modality of therapy (obstructive polyps,
tumors, infection of dental origin).
15. Subject has a psychiatric, addictive, or any disorder that compromises
ability to give truly Informed Consent for participation in this study.
16. Patient is currently enrolled in other investigational drug trial(s) or is
receiving other investigational agent(s).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Is there a significant difference in the VAS symptom score between saline only<br /><br>nasal irrigations versus xylitol/saline irrigations?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>is there a significant difference in the SNOT-22 score and objective nasal<br /><br>endoscopic findings, between saline only nasal irrigations versus<br /><br>xylitol/saline irrigations?</p><br>