Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor Rhinitis (NCT07266688) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor Rhinitis
Italy120 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Peak Nasal Inspiratory Flow (PNIF)
Timeframe: 20 days
Trial details
NCT IDNCT07266688
SponsorLiaquat University of Medical & Health Sciences