NCT00210015已完成2 期
A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 630
- 主要终点
- total nasal symptom score
研究概览
简要总结
The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.
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
- Double
入排标准
- 接受健康志愿者
- 否
入选标准
- •Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
- •Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
- •Have not started or had a change in immunotherapy regimen.
排除标准
- •Have a physical obstruction in the nose.
- •Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
- •Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
- •Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
- •Have asthma of sufficient severity to require use of excluded medications.
- •Have taken any medications excluded as listed in the protocol.
- •Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
- •Are a current smoker, recent smoker or past smoker as defined in the protocol.
结局指标
主要结局
total nasal symptom score
次要结局
- laboratory tests
- global assessment of perennial allergic rhinitis symptoms
- physical and anterior nasal exams
- vital signs
- adverse events
- change from baseline in quality of life assessments
- instantaneous assessment of symptoms
- ECG
- average total nasal symptom scores over various timepoints average individual symptom scores
研究者
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