Xylitol vs Saline Nasal Irrigations in CF-CRS

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Xylitol Nasal Irrigations in the Treatment of Chronic Rhinosinusitis in Cystic Fibrosis Patients: a Randomized Crossover Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05531630
• Other study ID #: S66364
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 of CF patients. 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 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.

Patients with cystic fibrosis, >18 years of age, who are known to have CRS with/without nasal polyps and who experience sinonasal symptoms in daily life, will be recruited (n=38). Patients with a visual analogue scale (VAS) score of >30/100 mm are included. Patients with a VAS <30 mm or patients who started <6 months ago with a CFTR modulator (eg Trikafta, Symkevi, Kalydeco) are excluded. After signing the ICF, patients are randomly allocated to a treatment arm "AB" or "BA". Patients in the study group 'AB' start, after a washout period of one week, with nasal rinses with Xylitol for six weeks. Afterwards, after another one week washout period, patients are asked to rinse the nose with standard saline nasal rinses without Xylitol for six weeks. Patients in the 'BA' group first start with standard nasal rinses, followed by Xylitol.

In total there are three planned study visits: a screening visit, a follow-up visit after the first treatment period and a follow-up visit after the second treatment period. During these visits, a nasal endoscopy (Lund-Kennedy and Modified Davos score) and smell tests (Sniffin' Sticks) are performed. In addition, the patients are asked to complete a questionnaire with VAS scores, the SNOT-22 score and the TRE score. Data is collected in a REDCAP database. Afterwards, the outcome parameters are statistically compared between the SNI and the XNI group.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: September 30, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients <18 years old

• Start of CFTR gene-modulator less than 6 months prior to inclusion

• 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)

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Device:
• Nasal rinsing with saline 0.9%
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).
• Nasal rinsing with Xylitol
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.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Visual analogue scale for total sinus symptom	questionnaire, scale from 0-100	3 months
Primary	Difference in SNOT-22 score	questionnaire, scale from 0-110	3 months
Primary	Difference in Thereapeutic response evaluation	questionnaire, scale from 1-5	3 months
Secondary	Difference in VAS for individual sinonasal symptoms	questionnaire, scale from 0-100	3 months
Secondary	Difference in VAS for major sinus symptom	questionnaire, scale from 0-100	3 months
Secondary	Difference in Lund-kennedy score	Endoscopy score (0-12)	3 months
Secondary	Difference in Modified Davos score	Endoscopy score (0-8)	3 months
Secondary	Difference in Olfactory function	Identification using Sniffin' sticks test, scale 0-16	3 months