Xylitol vs Saline Nasal Irrigations in CF-CRS

NCT05531630 | Enrolling By Invitation

• 1 other identifier: S66364
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis (CF) is the most common genetic disorder in Belgium, affecting 1 in 2850 children. A defect in the CFTR channel results in increased viscosity of extracellular secretions and decreased mucociliary clearance in the airways. As a result of this mechanism, chronic rhinosinusitis (CRS) occurs in nearly 100% of CF patients. CRS can lead to pronounced sinonasal complaints and can have a negative impact on the quality of life. In addition, several studies have shown that poor upper airway control has a negative impact on the lower airways. Unfortunately, treatment options are limited. Our previous study has shown that only 21% of patients have well-controlled CRS. The aim of this single-center, randomized cross-over study is to compare the effect of nasal rinses with (XNI) and without (SNI) Xylitol in the treatment of CF-CRS. Xylitol is a sugar alcohol that is already used as an antibiofilm agent,eg in the prevention of caries. Previous pilot studies have already shown a beneficial effect of XNI in the treatment of non-CF CRS.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

chronic rhinosinusitis; cystic fibrosis; nasal rinsing; xylitol; saline; nasal polyps

Outcome Measures

Primary Outcomes (3)

• Difference in Visual analogue scale for total sinus symptom

  questionnaire, scale from 0-100

  3 months

• Difference in SNOT-22 score

  questionnaire, scale from 0-110

  3 months

• Difference in Thereapeutic response evaluation

  questionnaire, scale from 1-5

  3 months

Secondary Outcomes (5)

• Difference in VAS for individual sinonasal symptoms

  3 months

• Difference in VAS for major sinus symptom

  3 months

• Difference in Lund-kennedy score

  3 months

• Difference in Modified Davos score

  3 months

• Difference in Olfactory function

  3 months

Study Arms (2)

AB: Xylitol-Saline

EXPERIMENTAL

Patients in the AB arm will first receive Xylitol, followed by saline

Device: Nasal rinsing with saline 0.9%; Device: Nasal rinsing with Xylitol

BA: Saline-Xylitol

EXPERIMENTAL

Patients in the BA arm will first receive saline, followed by Xylitol

Device: Nasal rinsing with saline 0.9%; Device: Nasal rinsing with Xylitol

Interventions

Nasal rinsing with saline 0.9% DEVICE

Nasal irrigations with saline (NaCl 0.9%) are considered golden standard in the treatment of chronic rhinosinusitis. Sachets consisting of mixtures for saline solutions, produced by DOS Medical®, consist of 1.875g sodium chloride and 0.625g sodium bicarbonate (figure 5). The content of the sachet has to be dissolved in 250mL heated water (lukewarm drinking water, max 37°C) in a NasoFree® nasal irrigator (Figure 4). Afterwards, the solution has to be mixed according to the instructions, the temperature has to be tested on the palm or forearm and afterwards, the product can be used. The patient will be asked to rinse their nose with the saline solution, once daily, for six weeks. The sachet with rinsing salt is considered to be a class I medical device and has a CE-label (CNK number 3309028).

AB: Xylitol-Saline; BA: Saline-Xylitol

Nasal rinsing with Xylitol DEVICE

Xylitol is a sugar-alcohol that is already implemented in the treatment of patients with (difficult-to-treat) chronic rhinosinusitis. Some (pilot) studies have already showed a positive effect in CRS patients without cystic fibrosis. Xylitol nasal rinsing salt, produced by DOS Medical®, is a mixture of 4g Xylitol, 1.875g sodium chloride, 0.625g sodium bicarbonate and 0,03g mint (Figure 3). The content of the sachet has to be dissolved in 250mL heated water (lukewarm drinking water, max 37°C) in a NasoFree® nasal irrigator (Figure 4). Afterwards, the solution has to be mixed according to the instructions, the temperature has to be tested on the palm or forearm and afterwards, the product can be used. The patient will be asked to rinse their nose with the Xylitol solution, once daily, for six weeks. The sachet with rinsing salt is considered to be a class I medical device, has a CE-label (CNK number 3309036) and is already commercially available in Belgium and The Netherlands.

AB: Xylitol-Saline; BA: Saline-Xylitol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with established diagnosis of cystic fibrosis \> 18 years old
• Routine follow-up at UZ Leuven
• Patients with established diagnosis of chronic rhinosinusitis, with or without nasal polyps, and with a VAS-score of \>30 out of 100 for at least one individual sinonasal symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, reduced smell)
• Willing to participate in this study and compliant to the treatment

You may not qualify if:

• Patients \<18 years old
• Not willing to participate in this trial or incompliant to the trial
• History of severe epistaxis (\<6 months), requiring intervention by an ENT specialist
• History of hypersensitivity/allergic reaction/anaphylactic shock to one of the compounds of the sachets (NaCl, bicarbonate, mint, Xylitol)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Disease; Cystic Fibrosis; Nasal Polyps

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Study Officials

• Laura Van Gerven, MD, PhD

  Department of Otorhinolaryngology, UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be designed as a blinded trial, in which nor the investigator, nor the patient will know the sequence of the treatments (AB or BA). The patients will receive a box with sachets for treatment period 1 at the screening visit. The box will have a number from 1 to 76 and the sachets from both treatment groups will not contain any information regarding the content.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be asked to perform nasal irrigations with both Xylitol (treatment A) and saline (treatment B) once daily for six weeks, with a washout period of one week before the start of the treatment and one week between the two treatment periods. Washout periods are included to reduce the risk for a carryover effect. Patients will be randomized in two treatment arms: AB and BA. Patients in the AB arm will first receive Xylitol, followed by saline, and vice versa in the BA group.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 8, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)