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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Peak Nasal Inspiratory Flow (PNIF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study; no masking of participants or investigators.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Peak Nasal Inspiratory Flow (PNIF)
时间窗: 20 days
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).
次要结局
- Treatment Compliance(20 days)
- Change in Quality of Life Measured by SNOT-22(20 days)
- Change in Nasal Cytology (Rhinocytogram)(20 days)
- Incidence of Adverse Events(20 days)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences