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NOT YET RECRUITING
NCT07800273
NA

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

Sponsor: Liaquat University of Medical & Health Sciences

View on ClinicalTrials.gov

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

Interventions

DEVICE

Bactorinol® (manufacturer: PharmExtracta S.p.A.)

Bactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.

DRUG

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