A prospective comparative study to evaluate the efficacy, safety and cost-effectiveness of montelukast-fexofenadine and montelukast-bilastine in patients with allergic rhinitis in south indian population
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis using TNSS scoring system.
研究概览
简要总结
Persons diagnosed with Allergic Rhinitis will be divided randomly into two groups, A (Montelukast and Fexofenadine) and B (Montelukast and Bilastine) will be given daily at night in empty stomach and they will be followed up after 4 weeks with the TNSS score questionnaire.
Blood parameters such as CBC, LFT, RFT at baseline and after 4 weeks will be assessed.
Primary outcome will be the composite TNSS score at baseline and at 4th week.
Secondary outcome will be any adverse effects and cost effectiveness of the drugs.
Cost-effectiveness ratio is equal to cost divided by outcome
Outcome will be measured in terms of effectiveness. TNSS parameter is the main effectiveness parameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group of 18 to 65 years Both gender having moderate to severe intermittent or mild persistent Allergic rhinitis Patients with positive history of Bronchial Asthma Not treated with antihistaminics in the previous week Patients willing to sign written informed consent Complying with the study procedure Free of any clinically significant disease and having normal electrocardiography.
排除标准
- •Age less than 18 years Pregnant female Nursing mothers History of allergies to study medication or tolerance to antihistamines and use of study drug in the past 7 days Patients with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune diseases are excluded from the study.
结局指标
主要结局
To evaluate the efficacy of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis using TNSS scoring system.
时间窗: After 1 month
次要结局
- To evaluate the safety of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis by vigilant follow-up of patients for the treatment of emergent adverse events
- To evaluate the cost-effectiveness of Montelukast-Fexofenadine and Montelukast-Bilastine combination in patients with Allergic Rhinitis
研究者
Gokula Kannan S
ACS Medical College and Hospital