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Clinical Trials in Italy / NCT07800273
Starting soon Not applicable

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

NCT07800273 · tracked via the Priya Life Science Italy tracker
Sponsor
Liaquat University of Medical & Health Sciences
Phase
Not applicable
Started
2026-09-14
Last updated
2026-09-02

Condition(s) studied

Chronic Rhinosinusitis

Investigational drug(s) / intervention(s)

Bactorinol® (manufacturer: PharmExtracta S.p.A.)Mometasone Furoate Nasal Spray →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Patients diagnosed with chronic rhinosinusitis with nasal polyposis (CRSwNP) and without polyposis (CRSsNP) * Clinical indication for treatment with intranasal corticosteroid (mometasone furoate) * Ability to understand and sign informed consent * Willingness to comply with the study protocol and follow-up visits (T0, T12 weeks) Exclusion Criteria: * Neoplastic pathologies of all degrees * Neurological or psychiatric disorders such as to impair adherence to treatment and/or understanding of informed consent forms * Pregnancy and lactation * Chronic drug and/or alcohol use * Immunosuppressed subjects (primary immunodepression, oncological pathology undergoing active chemo/immunotherapy treatment, autoimmune pathology undergoing immunosuppressive treatment) * Allergy, even suspected, to one or more of the excipients of the preparation under study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Armonia Centro Polispecialistico Porto Mantovano Lombardy

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Other trials for the same condition

Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07800273 on ClinicalTrials.gov ↗ ← All trials in Italy