Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Cetirizine 10 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
- 683
- 主要终点
- Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.
研究概览
简要总结
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.
详细描述
In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.
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
- •Patients of either sex between 12 and 70 years of age.
- •Patients with documented clinical history of SAR, for at least 2 years prior to the study inclusion.
- •Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.
- •A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted for inclusion, if performed within 12 months prior to the inclusion.
排除标准
- •Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).
- •Negative skin prick test (as defined in point 6.1.1.).
- •Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months. Any other nasal illness that can interfere with the aim of the study.
- •Patients who have acute or chronic sinusitis as judged by the investigator.
- •Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.
- •Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period
研究组 & 干预措施
A
Bilastine
干预措施: bilastine (Drug)
B
Cetirizine
干预措施: Cetirizine (Drug)
C
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.
时间窗: 14 days
次要结局
- AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.(14 days)
- Change from baseline at day 7 and day 14 for the following: Patient-rated (reflective and instantaneous) and Investigator-rated (instantaneous; assessed during study visit) TSS, NSS, NNSS and change for each individual symptom.(14 days)
- Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.
- Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14
- Responders Rate: responders will be classified based on their TSS decrease from baseline: no responders (<25%), >25%<50%, >50%<75%, >75% and will be described by treatment group with their percentage