Clinical Trial

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

Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-24.
Status change: Not Yet Recruiting → Completed 2026-04-20
Trial Details
NCT Number NCT07266688
Lead Sponsor Liaquat University of Medical & Health Sciences
Collaborators: University of Urbino "Carlo Bo"
Conditions Vasomotor Rhinitis
Enrollment 120 participants
Start Date 2025-12-01
Primary Completion 2026-04-20 (estimated)
Study Completion 2026-04-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-23