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Not Yet Recruiting NCT07787494

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

Conditions: Chronic Rhinosinusitis (CRS)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Liaquat University of Medical & Health Sciences

Location: Armonia Centro Polispecialistico Armonia Centro Polispecialistico Porto Mantovano

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07787494). StuddyBuddy aggregates publicly available trial information.