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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50402
Enrollment
66
Registered
2017-04-13
Start date
2017-06-30
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis

Interventions

nvt

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Is there a significant difference in the VAS symptom score between saline only nasal irrigations versus xylitol/saline irrigations?

Secondary

MeasureTime frame
is there a significant difference in the SNOT-22 score and objective nasal endoscopic findings, between saline only nasal irrigations versus xylitol/saline irrigations?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)