Bactorinol® Nasal Spray With Reduced-Dose Mometasone in Adults With Chronic Rhinosinusitis

Effect of a Corticosteroid-Sparing Regimen Including Pistacia Lentiscus Oil Nasal Spray on Quality of Life in Patients With Chronic Rhinosinusitis: A Randomized Controlled Study

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.

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.

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