Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses, defined by the presence of symptoms for at least 12 weeks. Medical treatment of CRS is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance. However, despite these treatments, some patients continue to experience persistent or recurrent symptoms.
This prospective, single-center, randomized, controlled, non-profit study aims to evaluate the clinical efficacy of Bactorinol® nasal spray in patients with chronic rhinosinusitis, in order to reduce the impact of CRS symptoms on patients' quality of life in a non-inferior manner compared with treatment with the full dose of mometasone furoate nasal spray.
Participants will be randomly assigned in a 1:1 ratio to receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily, or mometasone furoate nasal spray 2 puffs daily. The treatment period will last 12 weeks.
Age ≥18 years
Patients diagnosed with chronic rhinosinusitis with nasal polyposis (CRSwNP) and without polyposis (CRSsNP)
Clinical indication for treatment with intranasal corticosteroid (mometasone furoate)
Ability to understand and sign informed consent
Neoplastic pathologies of all degrees
Neurological or psychiatric disorders such as to impair adherence to treatment and/or understanding of informed consent forms
Pregnancy and lactation
Chronic drug and/or alcohol use
Parallel
Bactorinol® (manufacturer: PharmExtracta S.p.A.)
DeviceBactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.
Mometasone Furoate Nasal Spray
DrugMometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily.
Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)
Change in the impact of chronic rhinosinusitis symptoms on patients' quality of life will be assessed using the validated Sino-Nasal Outcome Test-22 (SNOT-22) scale in both study groups.
Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)
Change in nasal congestion severity will be assessed using the Congestion Quantifier 7-item test (CQ7) in both study groups.
Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)
Change in rhinorrhea intensity will be assessed using a Visual Analog Scale (VAS) from 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptom.
Antibiotic Use During the Study
Antibiotic use will be assessed by recording the number of doses used and the total number of days of antibiotic use during the study period.
Incidence of Adverse Events During Treatment
The incidence of adverse events due to treatment will be assessed through recording of adverse events in the data collection form throughout the study period.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
