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