NCT03655210已完成3 期
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Changes in total rTNSS(Reflective TNSS) score
研究概览
简要总结
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial
详细描述
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial to Evaluate the Efficacy and Safety of HL151 versus Placebo in perennial allergic rhinitis patients
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender, 19 years ≤ age
- •At least two years history of allergic rhinitis prior to participate in clinical trial
- •Patients with positive reaction for perennial allergen in tests(prick test or Intradermal test or MAST(Multiple Allergen Simultaneous Test) or Immuno CAP test) within 12 months
- •In visit 2, patients with over mean 5 points of the total reflective TNSS score per day (during the run-in period) (highest value 12 points)
- •Patients who can ability to record subject diary
- •Patients who agreed to maintain the same environment throughout the entire clinical trial period.
- •Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial
排除标准
- •Patients with non-allergic rhinitis
- •Patients with asthma due to the following diseases(but patients with mild and intermittent asthma are available to participate in clinical trials)
- •Within four weeks from the date of screening, patients who visit the emergency room or have been hospitalized within 12 weeks or
- •patients with asthma who need other treatment except short-acting Beta-efficient respiratory relaxants Inhalation
- •Patients with obstructive nasal polyp or severe deviated nasal septum
- •Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity
- •Patients with anamnesis in acute /chronic sinusitis
研究组 & 干预措施
Experimental
Experimental
HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment
干预措施: HL151 (Drug)
Placebo Comparator
Placebo Comparator
HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment
干预措施: placebo (Drug)
结局指标
主要结局
Changes in total rTNSS(Reflective TNSS) score
时间窗: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline
次要结局
- Changes in rTNSS(Reflective TNSS) score(Visit 2 (0 week), Visit 3 (2 weeks))
- Changes in iTNSS(Instananeous TNSS) score(Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks))
- Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)(Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks))
- Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)(Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks))
- Investigator's assessment of overall treatment(Visit 4 (4 weeks))
研究者
研究点 (1)
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