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Bactorinol® Nasal Spray With Reduced-Dose Mometasone in Adults With Chronic Rhinosinusitis
Sponsor: Liaquat University of Medical & Health Sciences
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2026-09-14
Completion Date
2027-05-31
Last Updated
2026-09-02
Healthy Volunteers
No
Conditions
Interventions
Bactorinol® (manufacturer: PharmExtracta S.p.A.)
Bactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.
Mometasone 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.
Locations (1)
Armonia Centro Polispecialistico
Porto Mantovano, Lombardy, Italy