A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,671
- 试验地点
- 1
- 主要终点
- The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline
研究概览
简要总结
Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.
After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).
详细描述
A Multi-center, Prospective, Observational Study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female aged ≥ 15 years
- •Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
- •Patients who provided a signed written informed consent form
排除标准
- •Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
- •Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
- •A female who is pregnant, may be pregnant, or is lactating
- •Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
结局指标
主要结局
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline
时间窗: 3 Month
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline. \*TNSS: Total symptom scores for nasal congestion, sneezing, runny nose and nasal itching during the daytime in the past week
次要结局
- The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline(6Month)
- The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline(3Month,6Month)
- Occurrence and frequency of adverse events(6Month)
- The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline(3Month,6Month)
- The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline(3Month,6Month)