NCT04324918已完成3 期
Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2018年10月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change of Mean Daytime Nasal Symptom Score
研究概览
简要总结
Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial
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 (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 2 years history of PAR prior to the study
- •Positive results of skin prick test
- •Patients who provided a signed written informed consent form
- •Patients who are able and willing to complete subject diaries
- •Patients who agree to maintain consistency in their surroundings throughout the study period
排除标准
- •Patients also with non-allergic rhinitis with different causes.
- •Patients with severe asthma.
- •History of acute • chronic sinusitis within 1 month of Visit 1
- •History of intranasal surgeries within 3 months of Visit 1
- •Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
- •Upper respiratory infections including cold and systemic infections within 3 weeks of Visit
- •Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.
研究组 & 干预措施
HCP1102
Experimental
干预措施: HCP1102 (Drug)
HGP1408
Active Comparator
干预措施: HGP1408 (Drug)
结局指标
主要结局
Change of Mean Daytime Nasal Symptom Score
时间窗: base line, 3-4week(2weeks)
Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).
次要结局
- Change of Mean Nighttime Nasal Symptom Score(baseline, 3-4week(2weeks))
研究者
研究点 (1)
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