NCT00295022已完成4 期
Double-blind, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
UCB S.A. - Pharma Sector0 个研究点目标入组 418 人开始时间: 2006年7月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 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
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- •Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the 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)
Placebo Comparator
Placebo was administered orally on Days 1 and 2.
干预措施: Placebo (Drug)
Montelukast (MLKT)
Experimental
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
干预措施: Montelukast (Drug)
Levocetirizine (LCTZ)
Experimental
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
干预措施: Levocetirizine (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, from 9:30 am to 11:00 am])
- Change From Baseline in the MSC Score Over Period III(Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm])
- Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)(Baseline to Day 2)
- Change From Baseline in the Total Symptom Complex (TSC) Score 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 Total Symptom Complex (TSC) Score Over Period II(Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am])
- Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III(Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm])
- Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)(Baseline to Day 2)
- Change From Baseline in the TSC Score + Nasal Congestion Score 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 TSC Score + Nasal Congestion Score Over Period II(Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am])
- Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III(Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm])
- Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)(Baseline to Day 2)
- 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, from 9:30 am to 11:00 am])
- Change From Baseline in the Individual Symptom Scores Over Period III(Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm])
- Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)(Baseline to Day 2)
- Time to First Feeling of Improvement During Period I(During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)])
- Onset of Action During Period I(During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)])
- Intensity of Action From Baseline in the MSC Score Over Period I(Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)])
- Intensity of Action From Baseline in the MSC Score Over Period II(Treatment Period II [Day 2, from 9:30 am to 11:00 am])
- Intensity of Action From Baseline in the MSC Score Over Period III(Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm])
- Variability of Action From Baseline in the MSC Score Over Period I(Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)])
- Variability of Action From Baseline in the MSC Score Over Period II(Treatment Period II [Day 2, from 9:30 am to 11:00 am])
- Variability of Action From Baseline in the MSC Score Over Period III(Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm])
- Global Satisfaction of the Subjects at the End of Period III(At the end of Period III (Day 2))
- Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season(At the end of Period III (Day 2))
研究者
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