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

Evaluation of the Efficacy and Safety of Treatment With a Medical Device Containing Pistacia Lentiscus in Patients With Vasomotor Rhinitis: A Multicenter, Prospective, Randomized, Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Vasomotor Rhinitis
• Intervention / Treatment: Device: Bactorinol® Nasal Spray; Other: Isotonic Saline Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pesaro E Urbino
    • Urbino, Pesaro E Urbino, Italy, 61029
      • Università di Urbino Carlo Bo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Bactorinol® Nasal Spray; Bactorinol® nasal spray containing winterized Pistacia lentiscus oil. Administered as 3 puffs per nostril, three times daily for 20 consecutive days.; Other Names: Winterized Pistacia lentiscus oil nasal spray
Active Comparator: Isotonic Saline Solution (Control Arm); Participants receive isotonic saline solution nasal spray. Dosage: 3 administrations per nostril, three times daily for 20 consecutive days.	Other: Isotonic Saline Solution; Isotonic saline nasal spray administered as 3 sprays per nostril, three times daily for 20 consecutive days.; Other Names: Normal saline nasal spray (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Measured by SNOT-22	Quality of life will be assessed using the validated Sino-Nasal Outcome Test (SNOT-22) questionnaire at baseline and at the end of treatment.	20 days
Change in Nasal Cytology (Rhinocytogram)	Nasal cytology will be evaluated using a rhinocytogram, assessing quantitative and semi-quantitative cellular components including neutrophils, metachromatic cells, goblet cells, eosinophils, mast cells, bacteria, spores/fungi, and presence of biofilm.	20 days
Treatment Compliance	Compliance will be assessed by counting returned product at the end of treatment and verifying the number of nebulizations performed.	20 days
Incidence of Adverse Events	All adverse events reported by participants or observed by investigators during the study period will be recorded.	20 days

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of Urbino "Carlo Bo"

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): April 20, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Vasomotor
• Other Study ID Numbers: 116/22.11.2024/BACTORINOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No