NCT01614691已完成2 期
Safety and Efficacy of SPARC1203 in Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change in Total Nasal Symptom Score (TNSS)
研究概览
简要总结
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test
排除标准
- •History or presence of perennial allergic rhinitis
- •Upper or lower respiratory tract infection 2 weeks before Visit 2
- •Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
- •Immunizations or vaccinations within 4 weeks prior to Visit 1
研究组 & 干预措施
SPARC1203 low dose
Experimental
干预措施: SPARC1203 (Drug)
SPARC1203 mid dose
Experimental
干预措施: SPARC1203 (Drug)
SPARC1203 high dose
Experimental
干预措施: SPARC1203 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Nasal Symptom Score (TNSS)
时间窗: Baseline and 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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