Xylitol vs Saline Nasal Irrigations in CF-CRS
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 2, 2022
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect 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 of CF patients. In addition, several studies have shown that poor upper airway control has a negative impact on the lower airways. Unfortunately, treatment op...
Gender
ALL
Eligibility criteria
- 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)
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Patients applied
Trial Officials
Laura Van Gerven, MD, PhD
Principal Investigator
Department of Otorhinolaryngology, UZ Leuven
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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