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NCT07787494
NA

Pistacia Lentiscus Oil Nasal Spray With Reduced-Dose Mometasone in 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. 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-09-07

Completion Date

2027-07-30

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

DRUG

Mometasone furoate - intranasal application

Mometasone furoate nasal spray administered at 2 puffs daily during the first 12-week treatment period. During the subsequent 12-week treatment period, the dose is reduced to 1 puff daily and administered in combination with Bactorinol® nasal spray.

DEVICE

Bactorinol nasal spray

Bactorinol® nasal spray is a medical device containing a patented formula of winterized Pistacia lentiscus oil. During the second 12-week treatment period, participants use Bactorinol® nasal spray at a dose of 3 puffs per nostril twice daily, in combination with mometasone furoate nasal spray 1 puff daily.

Locations (1)

Armonia Centro Polispecialistico

Armonia Centro Polispecialistico, Porto Mantovano, Italy