NCT00561717已完成4 期
A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis
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
- Bayer
- 入组人数
- 70
- 主要终点
- Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline
研究概览
简要总结
Finding out how fast azelastine nasal spray works in subjects with hay fever.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
- •Positive response to skin prick test to ragweed allergen at screening;
- •Be willing to participate in the trial.
排除标准
- •History of hypersensitivity to azelastine;
- •Females who are pregnant or lactating;
- •Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
- •Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
- •Known non-responsiveness to antihistamines;
- •Alcoholism or drug abuse within 2 yrs. of screening;
- •Current or regular use within 6 months of any type of tobacco product;
- •Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
- •History of a positive test to HIV, TB, hepatitis B or C.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Azelastine and placebo (Drug)
Arm 2
Active Comparator
干预措施: Loratadine and Placebo (Drug)
Arm 3
Active Comparator
干预措施: Cetirizine and Placebo (Drug)
Arm 4
Placebo Comparator
干预措施: Placebo and Placebo (spray and Tablet) (Drug)
结局指标
主要结局
Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline
时间窗: Up to 6 hours
次要结局
- Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy(Effect over 6 hours)
研究者
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