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

NCT07800273 | Not Yet Recruiting DMC

• 1 other identifier: 178_9giugno2026_BACTORINOL(2)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)

  Change in the impact of chronic rhinosinusitis symptoms on patients' quality of life will be assessed using the validated Sino-Nasal Outcome Test-22 (SNOT-22) scale in both study groups.

  Baseline to Week 12

Secondary Outcomes (5)

• Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)

  Baseline to Week 12

• Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)

  Baseline to Week 12

• Antibiotic Use During the Study

  Baseline to Week 12

• Incidence of Adverse Events During Treatment

  Baseline to Week 12

• Severity of Adverse Events Assessed by CTCAE

  Baseline to Week 12

Study Arms (2)

Treated Group

EXPERIMENTAL

Mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril 2 times daily for 12 weeks.

Device: Bactorinol® (manufacturer: PharmExtracta S.p.A.); Drug: Mometasone Furoate Nasal Spray

Control Group

ACTIVE COMPARATOR

Mometasone furoate nasal spray 2 puffs daily for 12 weeks.

Drug: Mometasone Furoate Nasal Spray

Interventions

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

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

Also known as: Bactorinol® Nasal Spray

Treated Group

Mometasone Furoate Nasal Spray DRUG

Mometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily.

Control Group; Treated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Urbino "Carlo Bo": collaborator
• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

Armonia Centro Polispecialistico

Porto Mantovano, Lombardy, 46047, Italy

Location

Central Study Contacts

Prof. Davide Sisti, PhD

CONTACT

+39 0722 304637; davide.sisti@uniurb.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

IT (1)