Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 主要终点
- Quality of life in patients with allergic rhinitis
研究概览
简要总结
The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.
详细描述
This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
- •patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)
排除标准
- •pregnancy or breast-feeding;
- •non-allergic rhinitis (vasomotor, infectious or drug-induced);
- •known hypersensitivity to antihistamines;
- •clinical disorders that might affect the assessment;
- •nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
- •therapy with immunotherapy;
- •use of antihistamines or disodium cromoglycate within the past four weeks;
- •use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks;
- •use of topical antihistamines or nasal decongestants within the last 48 hours;
- •use of deposit steroid within the last month.
研究组 & 干预措施
Bilastine group
Bilastine 20 mg administered once a day for ten days.
干预措施: Bilastine (Drug)
Loratadine group
Loratadine 10 mg administered once a day for ten days.
干预措施: Loratadine (Drug)
结局指标
主要结局
Quality of life in patients with allergic rhinitis
时间窗: 10 days
Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)
次要结局
未报告次要终点
研究者
Jane da Silva
PhD
Universidade do Sul de Santa Catarina