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Pistacia Lentiscus Oil Nasal Spray With Reduced-Dose Mometasone in Chronic Rhinosinusitis
Sponsor: Liaquat University of Medical & Health Sciences
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
Conditions
Interventions
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.
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