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

NCT07266688 | Completed DMC

• 1 other identifier: 116/22.11.2024/BACTORINOL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasomotor Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in Peak Nasal Inspiratory Flow (PNIF)

  PNIF will be measured using a Peak Nasal Inspiratory Flow meter to assess nasal airflow. The value at baseline (Visit 1) will be compared with the value at the end of treatment (Visit 2).

  20 days

Secondary Outcomes (4)

• Change in Quality of Life Measured by SNOT-22

  20 days

• Change in Nasal Cytology (Rhinocytogram)

  20 days

• Treatment Compliance

  20 days

• Incidence of Adverse Events

  20 days

Study Arms (2)

Bactorinol® Nasal Spray (Treatment Arm)

EXPERIMENTAL

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

Device: Bactorinol® Nasal Spray

Isotonic Saline Solution (Control Arm)

ACTIVE COMPARATOR

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

Other: Isotonic Saline Solution

Interventions

Bactorinol® Nasal Spray DEVICE

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

Also known as: Winterized Pistacia lentiscus oil nasal spray

Bactorinol® Nasal Spray (Treatment Arm)

Isotonic Saline Solution OTHER

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

Also known as: Normal saline nasal spray (Control)

Isotonic Saline Solution (Control Arm)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Università di Urbino Carlo Bo

Urbino, Pesaro E Urbino, 61029, Italy

Location

MeSH Terms

Conditions

Rhinitis, Vasomotor

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study; no masking of participants or investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Two-arm, parallel-group, randomized controlled design with 1:1 allocation to Bactorinol® nasal spray or isotonic saline solution.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)