Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Cetirizine 10 mg Oral Tablets to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 551
- 主要终点
- Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
研究概览
简要总结
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
- •Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- •Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol
排除标准
- •Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- •Have used forbidden concomitant medications as defined by the protocol
研究组 & 干预措施
Placebo (PBO)
A single dose of placebo was administered orally on Day 1.
干预措施: Placebo drops (Drug)
Placebo (PBO)
A single dose of placebo was administered orally on Day 1.
干预措施: Placebo tablets matching to levocetirizine (Drug)
Placebo (PBO)
A single dose of placebo was administered orally on Day 1.
干预措施: Placebo tablets matching to cetirizine (Drug)
Levocetirizine (LCTZ) 2.5 mg
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
干预措施: Levocetirizine drops (Drug)
Levocetirizine (LCTZ) 5 mg
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
干预措施: Levocetirizine tablets (Drug)
Cetirizine (CTZ) 5 mg
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
干预措施: Cetirizine drops (Drug)
Cetirizine (CTZ) 10 mg
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
干预措施: Cetirizine tablets (Drug)
结局指标
主要结局
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
时间窗: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
次要结局
- Change From Baseline in the MSC Score Over Period II(Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)])
- Change From Baseline in the Individual Symptom Scores Over Period I(Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)])
- Change From Baseline in the Individual Symptom Scores Over Period II(Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)])
- Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)(Baseline to Day 2)
- Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I(Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)])
- Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II(Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)])
- Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)(Baseline to Day 2)
- Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)(Baseline to Day 2)