Pistacia Lentiscus Oil Nasal Spray With Reduced-Dose Mometasone in Chronic Rhinosinusitis

Pistacia Lentiscus Oil Nasal Spray Combined With Reduced-dose Mometasone for Maintaining Quality-of-life Improvements Achieved With Full-dose Mometasone in Patients With Chronic Rhinosinusitis: A Single-arm, Single-sequence, Two-period Clinical Trial

Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses. Medical treatment is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance, including intranasal corticosteroids and nasal saline irrigations.

This interventional, prospective, single-arm, single-sequence, two-period study aims to evaluate the maintenance of clinical control of chronic rhinosinusitis during dose reduction of mometasone and introduction of Bactorinol® nasal spray, in order to evaluate the possible compensatory role of the medical device compared with the full dose of mometasone.

Participants will receive mometasone furoate nasal spray 2 puffs daily during the first 12 weeks, followed by 12 weeks of mometasone furoate nasal spray 1 puff daily combined with Bactorinol® nasal spray 3 puffs per nostril twice daily. Clinical outcomes will be compared between the two treatment periods.

Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses, characterized by symptoms lasting for at least 12 weeks. CRS may occur with or without nasal polyposis and can have a significant impact on quality of life, including nasal breathing, sleep, daily activities, work performance, and general well-being.

Medical treatment of CRS is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance. Intranasal corticosteroids and nasal saline irrigations are recommended for symptom relief. However, despite these treatments, some patients continue to experience persistent or recurrent symptoms and may require additional therapies and/or antibiotic courses.

Bactorinol® nasal spray (manufacturer: PharmExtracta S.p.A.) is a medical device based on winterized Pistacia lentiscus oil and is indicated as a support in cases of nasal congestion, promoting the fluidification of secretions and soothing irritated nasal mucosa. Pistacia lentiscus derivatives have been described as having potential antimicrobial, antioxidant, and anti-inflammatory properties, providing a rationale for evaluating Bactorinol® nasal spray as a topical adjuvant in patients with CRS.

This is an interventional, prospective, single-arm, single-sequence clinical trial with a two-period design and intra-subject comparison. The study aims to evaluate the maintenance of clinical control of chronic rhinosinusitis during dose reduction of mometasone and introduction of Bactorinol® nasal spray. The design allows evaluation of the non-inferiority in clinical efficacy of Bactorinol® nasal spray combined with half a dose of mometasone furoate, compared with results obtained in the same participants during the preceding period with full-dose mometasone furoate.

The total treatment duration for each participant is 24 weeks. During the first 12 weeks, participants will receive mometasone furoate nasal spray 2 puffs daily. During the subsequent 12 weeks, participants will receive mometasone furoate nasal spray 1 puff daily combined with Bactorinol® nasal spray 3 puffs per nostril twice daily.

Clinical assessments will be performed at enrollment (T0), after 12 weeks (T12), and after 24 weeks (T24). The impact of chronic rhinosinusitis symptoms on quality of life will be assessed using the Sino-Nasal Outcome Test-22 (SNOT-22). Nasal congestion will be assessed using the Congestion Quantifier Seven-Item Test (CQ7), and rhinorrhea intensity will be assessed using a 0-10 visual analogue scale (VAS). Antibiotic use will be recorded during the two study periods. Adverse events will be monitored throughout the study, and adherence and tolerability will be assessed during the Bactorinol® treatment period.

Inclusion Criteria:

• Age ≥18 years.
• Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) or without nasal polyposis (CRSsNP).
• Clinical indication for treatment with an intranasal corticosteroid (mometasone furoate).
• Ability to understand and sign informed consent.
• Willingness to comply with the study protocol and follow-up visits.

Exclusion Criteria:

• Neoplastic pathologies of all degrees.
• Neurological or psychiatric disorders that may impair adherence to treatment and/or understanding of the informed consent form.
• Pregnancy or lactation.
• Chronic drug and/or alcohol use.
• Immunosuppression, including primary immunodepression, oncological pathology undergoing active chemotherapy/immunotherapy, or autoimmune pathology undergoing immunosuppressive treatment.
• Known or suspected allergy to one or more excipients/components of the preparation under study.