A Phase III, Comparative Study for the Efficacy and Safety of Bilastine 20 mg Versus Cetirizine 10 mg and Placebo in the Treatment of Perennial Allergic Rhinitis During 4 Weeks, Followed by a Long-term Safety Extension With Bilastine 20 mg
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 650
- 主要终点
- Double-blind phase: AUC of TSS throughout the study
研究概览
简要总结
Double-blind phase: The objective of the study was to evaluate the efficacy and safety of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic rhinitis.
Open-label Phase: The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis
详细描述
Double-blind, randomized, placebo-controlled, parallel-group, international, multicenter study followed by an open label extension. Duration of the double-blind period was 28 days and the duration of the open label period was 12 additional months.
The primary efficacy variable of the double-blind period was the area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms. 650 patients were included in the study and 614 completed the double-blind phase. Out of the 614 patients who completed the double blind period, a total of 513 patients started the open label period with Bilastine 20 mg (83.6%)
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 aged from 12 to 70 years of age
- •Patients with a documented clinical history of PAR for at least 2 years prior to the study inclusion
- •Positive skin prick test for at least one of the following perennial allergens (house-dust mites, Dermatophagoides pteronyssinus or D. farinae, animal danders, dogs or cats, molds, etc.)
- •Patients had to have a sum in the previous 6 assessments of the reflective nasal symptoms score equal to or greater than 30 (≥30 over 72). Additionally, at the time of randomization patients had to have positive symptomatology in instantaneous nasal symptoms equal or greater than 5 (≥5 over 12).
- •Women of childbearing potential had to have a negative pregnancy test and had to use an effective contraceptive method.
- •Provision of written informed consent to participate and willing to attend the required visits scheduled in the protocol
- •The criteria to continue with the open label period included previous participation in the double blind period, eligibility for a long-term symptomatic treatment according to the investigator assessment and patient willingness to follow the treatment for one year.
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 are also diagnosed with SAR (seasonal allergic rhinitis), and the inclusion and follow-up during the double-blind phase in this study is concurrent with the pollen season.
- •Immunotherapy (6 months): In case of patients under immunotherapy the treatment had to have started more than 6 months prior to the start of the study, the doses could not be modified during the study, and any doses could not be administered 24 hours before any study visit..
- •Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period
- •Severe concomitant disease that could interfere with treatment response (hepatic, renal, cardiovascular), electrocardiographic abnormalities, arrhythmia, recent acute myocardial infarction or neoplastic diseases
研究组 & 干预措施
Bilastine
20 mg encapsulated tablets
干预措施: Bilastine (Drug)
Cetirizine
10 mg encapsulated tablets
干预措施: Cetirizine (Drug)
Placebo
Encapsulated tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Double-blind phase: AUC of TSS throughout the study
时间窗: 28 days
Area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms.
Open-label phase: Long-term safety
时间窗: 12 months
Evaluation of the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis. The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study), ECGs on M3, M6, M9 and M12 visits and routine laboratory analyses (haematology and biochemistry) performed at M3, M6, M9 and M12 visits.
次要结局
- AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.(28 days)
- Change in the TSS on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)(Day 14 and day 28)
- Change in Nasal Symptoms Score (NSS)(Day 14 and day 28)
- Change in Non Nasal Symptoms Score (NNSS)(Day 14 and day 28)
- Change in individual nasal and non nasal symptoms(Day 14 and day 28)
- AUC of NSS, NNSS and each individual nasal andn non nasal symptom(28 days)
- AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment(28 days)
- Overall assessment of discomfort(Day 14 and day 28)
- Investigator's clinical global impression(28 days)
- Quality of Life change from baseline(28 days)
- Responders rate(28 days)
- Time to maximum response(48 hours)
- Safety and tolerability(28 days)