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

NCT07800273 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-09-02

No results posted yet for this 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.

Conditions

  • Chronic Rhinosinusitis

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.

Sponsors & Collaborators

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-14
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800273 on ClinicalTrials.gov