Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 主要终点
- AUC of TSS
研究概览
简要总结
The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.
详细描述
Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
- •Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..
排除标准
- •Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
- •Patients were not allowed to take forbidden medications or not comply the study requirements.
- •Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
- •Pregnant or breast-feeding women were also excluded.
- •Women of childbearing potential had a pregnancy test done
研究组 & 干预措施
Bilastine
干预措施: Bilastine (Drug)
Desloratadine
干预措施: Desloratadine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AUC of TSS
时间窗: 14 days
The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.
次要结局
- Change in TSS. Reflective symptoms(14 days)
- Change in TSS. Instantaneous score(14 days)
- Change in total nasal symptom score (TNSS)(14 days)
- Change in total non-nasal symptom score (TNNSS)(14 days)
- VAS of discomfort(14 days)
- CGI(14 days)
- Allergic rhinitis (AR) quality of life (QoL) questionnaire(14 days)
- Onset of action(2 days)
- Safety assessment(14 days)