Effect of a Corticosteroid-Sparing Regimen Including Pistacia Lentiscus Oil Nasal Spray on Quality of Life in Patients With Chronic Rhinosinusitis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)
研究概览
简要总结
Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses, defined by the presence of symptoms for at least 12 weeks. Medical treatment of CRS is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance. However, despite these treatments, some patients continue to experience persistent or recurrent symptoms.
This prospective, single-center, randomized, controlled, non-profit study aims to evaluate the clinical efficacy of Bactorinol® nasal spray in patients with chronic rhinosinusitis, in order to reduce the impact of CRS symptoms on patients' quality of life in a non-inferior manner compared with treatment with the full dose of mometasone furoate nasal spray.
Participants will be randomly assigned in a 1:1 ratio to receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily, or mometasone furoate nasal spray 2 puffs daily. The treatment period will last 12 weeks.
详细描述
Bactorinol® nasal spray is a medical device based on winterized Pistacia lentiscus oil, indicated as a support in cases of nasal congestion, to promote the fluidification of secretions and soothe irritated nasal mucosa. Pistacia lentiscus derivatives have been described as having potential antimicrobial, antioxidant, and anti-inflammatory properties.
The study will evaluate whether the use of Bactorinol® nasal spray, included in a topical therapeutic strategy with intranasal corticosteroid, can improve quality of life and symptoms in patients with chronic rhinosinusitis. The study population includes patients diagnosed with chronic rhinosinusitis with nasal polyposis and without nasal polyposis.
This is a prospective, single-center, randomized, controlled study with a 1:1 allocation ratio. Participants will undergo a continuous 12-week treatment period. The treated group will receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily. The control group will receive mometasone furoate nasal spray 2 puffs daily.
Participants will be monitored throughout the study for safety, adherence, and clinical outcomes. Clinical evaluations and monitoring of adverse events will be performed at the beginning of the study and after 12 weeks of treatment.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients diagnosed with chronic rhinosinusitis with nasal polyposis (CRSwNP) and without polyposis (CRSsNP)
- •Clinical indication for treatment with intranasal corticosteroid (mometasone furoate)
- •Ability to understand and sign informed consent
- •Willingness to comply with the study protocol and follow-up visits (T0, T12 weeks)
排除标准
- •Neoplastic pathologies of all degrees
- •Neurological or psychiatric disorders such as to impair adherence to treatment and/or understanding of informed consent forms
- •Pregnancy and lactation
- •Chronic drug and/or alcohol use
- •Immunosuppressed subjects (primary immunodepression, oncological pathology undergoing active chemo/immunotherapy treatment, autoimmune pathology undergoing immunosuppressive treatment)
- •Allergy, even suspected, to one or more of the excipients of the preparation under study
研究组 & 干预措施
Treated Group
Mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril 2 times daily for 12 weeks.
干预措施: Bactorinol® (manufacturer: PharmExtracta S.p.A.) (Device)
Treated Group
Mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril 2 times daily for 12 weeks.
干预措施: Mometasone Furoate Nasal Spray (Drug)
Control Group
Mometasone furoate nasal spray 2 puffs daily for 12 weeks.
干预措施: Mometasone Furoate Nasal Spray (Drug)
结局指标
主要结局
Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)
时间窗: Baseline to Week 12
Change in the impact of chronic rhinosinusitis symptoms on patients' quality of life will be assessed using the validated Sino-Nasal Outcome Test-22 (SNOT-22) scale in both study groups.
次要结局
- Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)(Baseline to Week 12)
- Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)(Baseline to Week 12)
- Antibiotic Use During the Study(Baseline to Week 12)
- Incidence of Adverse Events During Treatment(Baseline to Week 12)
- Severity of Adverse Events Assessed by CTCAE(Baseline to Week 12)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences