Chronic Rhinosinusitis (Diagnosis)NCT05531630
Xylitol vs Saline Nasal Irrigations in CF-CRS
A study testing Nasal rinsing with saline 0.9% and Nasal rinsing with Xylitol in people with Chronic Rhinosinusitis (Diagnosis), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Nasal rinsing with saline 0.9% and Nasal rinsing with Xylitol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Xylitol Nasal Irrigations in the Treatment of Chronic Rhinosinusitis in Cystic Fibrosis Patients: a Randomized Crossover Trial
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.
Read the detailed 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.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Nasal rinsing with saline 0.9%, Nasal rinsing with Xylitol
- Keywords
- chronic rhinosinusitis, cystic fibrosis, nasal rinsing, xylitol, saline, nasal polyps
- Medical subject headings
- Disease, Cystic Fibrosis, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Nasal rinsing with XylitolDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AB: Xylitol-Saline | Experimental | Patients in the AB arm will first receive Xylitol, followed by saline Receives: 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 Receives: Device: Nasal rinsing with saline 0.9%; Device: Nasal rinsing with Xylitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Visual analogue scale for total sinus symptom
questionnaire, scale from 0-100
Measured: 3 months
Difference in SNOT-22 score
questionnaire, scale from 0-110
Measured: 3 months
Difference in Thereapeutic response evaluation
questionnaire, scale from 1-5
Measured: 3 months
Secondary outcomes (5)
Difference in VAS for individual sinonasal symptoms
questionnaire, scale from 0-100
Measured: 3 months
Difference in VAS for major sinus symptom
questionnaire, scale from 0-100
Measured: 3 months
Difference in Lund-kennedy score
Endoscopy score (0-12)
Measured: 3 months
Difference in Modified Davos score
Endoscopy score (0-8)
Measured: 3 months
Difference in Olfactory function
Identification using Sniffin' sticks test, scale 0-16
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Dec 2022
- Primary completion1 Aug 2023
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Van Gerven, MD, PhD, Principal investigator, Department of Otorhinolaryngology, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531630
- Sponsor's protocol ID
- S66364
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylitol Nasal Irrigations in the Treatment of Chronic Rhinosinusitis in Cystic Fibrosis Patients: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05531630
- Acronym / sponsor ID
- S66364
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- chronic rhinosinusitis, cystic fibrosis, nasal rinsing, xylitol, saline, nasal polyps
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AB: Xylitol-Saline | Experimental | Device: Nasal rinsing with saline 0.9%, Device: Nasal rinsing with XylitolPatients in the AB arm will first receive Xylitol, followed by saline |
| BA: Saline-Xylitol | Experimental | Device: Nasal rinsing with saline 0.9%, Device: Nasal rinsing with XylitolPatients in the BA arm will first receive saline, followed by Xylitol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | AB: Xylitol-Saline, BA: Saline-Xylitol |
| Nasal rinsing with XylitolXylitol 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. | Device | AB: Xylitol-Saline, BA: Saline-Xylitol |
Primary outcome
Difference in Visual analogue scale for total sinus symptom
Time frame: 3 months
questionnaire, scale from 0-100
Difference in SNOT-22 score
Time frame: 3 months
questionnaire, scale from 0-110
Difference in Thereapeutic response evaluation
Time frame: 3 months
questionnaire, scale from 1-5
5 secondary outcomes
Difference in VAS for individual sinonasal symptoms
Time frame: 3 months
Difference in VAS for major sinus symptom
Time frame: 3 months
Difference in Lund-kennedy score
Time frame: 3 months
Difference in Modified Davos score
Time frame: 3 months
Difference in Olfactory function
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Van Gerven, MD, PhD principal investigator
Department of Otorhinolaryngology, UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal rinsing with saline 0.9% and Nasal rinsing with Xylitol in people with Chronic Rhinosinusitis (Diagnosis), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Visual analogue scale for total sinus symptom (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.