Chronic Rhinosinusitis
Conditions
Brief summary
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.
Detailed description
Bactorinol® nasal spray is a medical device based on winterized Pistacia lentiscus oil, indicated as a support in cases of nasal congestion, to promote the fluidification of secretions and soothe irritated nasal mucosa. Pistacia lentiscus derivatives have been described as having potential antimicrobial, antioxidant, and anti-inflammatory properties. The study will evaluate whether the use of Bactorinol® nasal spray, included in a topical therapeutic strategy with intranasal corticosteroid, can improve quality of life and symptoms in patients with chronic rhinosinusitis. The study population includes patients diagnosed with chronic rhinosinusitis with nasal polyposis and without nasal polyposis. This is a prospective, single-center, randomized, controlled study with a 1:1 allocation ratio. Participants will undergo a continuous 12-week treatment period. The treated group will receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily. The control group will receive mometasone furoate nasal spray 2 puffs daily. Participants will be monitored throughout the study for safety, adherence, and clinical outcomes. Clinical evaluations and monitoring of adverse events will be performed at the beginning of the study and after 12 weeks of treatment.
Interventions
DEVICEBactorinol® (manufacturer: PharmExtracta S.p.A.)
Bactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.
DRUGMometasone Furoate Nasal Spray
Mometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Willingness to comply with the study protocol and follow-up visits (T0, T12 weeks)
Exclusion criteria
* 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 * Immunosuppressed subjects (primary immunodepression, oncological pathology undergoing active chemo/immunotherapy treatment, autoimmune pathology undergoing immunosuppressive treatment) * Allergy, even suspected, to one or more of the excipients of the preparation under study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22) | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events During Treatment | Baseline to Week 12 | 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. |
| Severity of Adverse Events Assessed by CTCAE | Baseline to Week 12 | The intensity of adverse events due to treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE). |
| Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS) | Baseline to Week 12 | 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. |
| Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7) | Baseline to Week 12 | Change in nasal congestion severity will be assessed using the Congestion Quantifier 7-item test (CQ7) in both study groups. |
| Antibiotic Use During the Study | Baseline to Week 12 | 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. |
Countries
Italy
Contacts
CONTACTProf. Davide Sisti, PhD
Outcome results
None listed