Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor Rhinitis

NCT ID: NCT07266688

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-05-29

Brief Summary

This study aims to evaluate the effectiveness and safety of Bactorinol® nasal spray, a medical device containing winterized Pistacia lentiscus oil, in adults with vasomotor rhinitis. Vasomotor rhinitis is a chronic condition characterized by nasal congestion, rhinorrhea, and impaired nasal airflow.

In this multicenter, prospective, randomized, controlled clinical trial, 100 adult participants will be assigned in a 1:1 ratio to receive either Bactorinol® nasal spray or isotonic saline solution for 20 consecutive days. The primary objective is to determine whether Bactorinol® improves nasal airflow, measured by Peak Nasal Inspiratory Flow (PNIF). Secondary objectives include evaluating changes in symptoms and quality of life using the SNOT-22 questionnaire, assessing nasal cytology, and monitoring treatment compliance and adverse events.

The results of this study may help identify a non-pharmacological, natural-extract-based treatment option for patients with vasomotor rhinitis.

Detailed Description

Vasomotor rhinitis is a chronic inflammatory condition of the nasal mucosa characterized by airflow obstruction, dysregulated mucus production, and impaired mucociliary clearance. Environmental factors, mucosal dryness, and alterations in epithelial function contribute to symptoms, and current treatment options are often limited or unsatisfactory.

Bactorinol® nasal spray is a medical device formulated with winterized Pistacia lentiscus oil, which contains terpenes and polyphenols with recognized emollient, anti-inflammatory, antibacterial, and antibiofilm properties. These characteristics may help reduce mucosal irritation, improve mucociliary function, and relieve nasal congestion.

This multicenter, prospective, randomized, controlled, parallel-group clinical trial will enroll 100 adults with a confirmed diagnosis of vasomotor rhinitis. Participants will be randomized 1:1 to receive either Bactorinol® nasal spray (3 puffs per nostril, three times daily) or isotonic saline solution with the same dosing schedule, for 20 days.

The primary endpoint is the change in nasal airflow as measured by Peak Nasal Inspiratory Flow (PNIF) from baseline to the end of treatment. Secondary assessments include changes in quality of life measured by the SNOT-22 questionnaire, nasal cytology via rhinocytogram, treatment compliance, and adverse events. Clinical and cytological evaluations will be performed at baseline and at the end of the 20-day treatment period.

The study is designed to determine whether Bactorinol® provides clinically meaningful improvement in nasal breathing and symptom burden in patients with vasomotor rhinitis and to assess its safety and tolerability when used as directed.

Conditions

Vasomotor Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bactorinol® Nasal Spray (Treatment Arm)

Participants receive Bactorinol® nasal spray containing winterized Pistacia lentiscus oil (medical device). Dosage: 3 puffs per nostril, three times daily for 20 consecutive days.

Group Type: EXPERIMENTAL

Bactorinol® Nasal Spray

Intervention Type: DEVICE

Bactorinol® nasal spray containing winterized Pistacia lentiscus oil. Administered as 3 puffs per nostril, three times daily for 20 consecutive days.

Isotonic Saline Solution (Control Arm)

Participants receive isotonic saline solution nasal spray. Dosage: 3 administrations per nostril, three times daily for 20 consecutive days.

Group Type: ACTIVE_COMPARATOR

Isotonic Saline Solution

Intervention Type: OTHER

Isotonic saline nasal spray administered as 3 sprays per nostril, three times daily for 20 consecutive days.

Interventions

Bactorinol® Nasal Spray

Bactorinol® nasal spray containing winterized Pistacia lentiscus oil. Administered as 3 puffs per nostril, three times daily for 20 consecutive days.

Intervention Type: DEVICE

Isotonic Saline Solution

Isotonic saline nasal spray administered as 3 sprays per nostril, three times daily for 20 consecutive days.

Intervention Type: OTHER

Other Intervention Names

Winterized Pistacia lentiscus oil nasal spray; Normal saline nasal spray (Control)

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged 18 to 70 years.
• Confirmed diagnosis of vasomotor rhinitis.
• Ability to understand the study procedures and provide written informed consent.
• Ability to follow study instructions.
• Availability to undergo scheduled evaluations.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Stenosing deviation of the nasal septum.
• Current or recurrent episodes of epistaxis.
• History of nasal endoscopic surgery within the past 6 months.
• Use of systemic antibiotics within the previous 30 days.
• Known hypersensitivity to any component of the study products.
• Concomitant topical medications applied to the nasal mucosa.
• Participation in another clinical trial or completion of another trial within the last month.
• Failure or unwillingness to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Urbino "Carlo Bo"

OTHER

Sponsor Role: collaborator

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università di Urbino Carlo Bo

Urbino, Pesaro E Urbino, Italy

Countries

Italy

Central Contacts

Prof. Davide Sisti, MD

Role: CONTACT

davide.sisti@uniurb.it

+39-0722-303301

Other Identifiers

116/22.11.2024/BACTORINOL

Identifier Type: -

Identifier Source: org_study_id