Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 924
- 试验地点
- 33
- 主要终点
- Profile of Asian AR patients prescribed with Dymista®
研究概览
简要总结
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice
详细描述
A) Primary objective:
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice; Patient's demographic;
Anamnestic background including:
- allergic and other comorbidities
- allergic conjunctivitis
- polysensitization
- current symptoms
- previous treatments of allergic rhinitis
- usage of current asthma reliever medication
- family history of allergy
B) Secondary Objective:
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The first prescription of Dymista® nasal spray according to the summary of product characteristics (SPC) and patient information leaflet and independently from the patient's enrollment in the study.
- •Patients with moderate to severe seasonal or perennial allergic rhinitis
- •For Hong Kong and Malaysia: Adult and children of age ≥ 12 years
- •For Taiwan: Adult and children of age ≥ 6 years.
- •For Thailand: Adults and children of age ≥ 12 years with seasonal and/or perennial allergic rhinitis OR children of age 6-11 years with only seasonal allergic rhinitis
- •Acute allergic rhinitis symptoms at the day of inclusion (i.e. VAS-Score ≥50 mm)
- •Signed informed consent/assent from the patient and, if applicable, the parent(s) or legal guardian(s) in compliance with local requirements.
- •Ability to understand and follow the instructions for using Dymista® nasal spray according to the patient information leaflet.
- •Willingness to complete and return the Patient Card.
排除标准
- •VAS score <50 mm on day of inclusion
- •Known allergic reaction from and/or intolerance to Dymista® nasal spray or any of the ingredients.
- •Pregnancy/planned pregnancy or breastfeeding during this NIS
- •Patients or parent(s)/legal guardians (as applicable) not able to fulfill study requirements according to the Investigator's opinion.
研究组 & 干预措施
Dymista®
Dymista® (Azelastine hydrochloride and Fluticasone propionate) nasal spray as prescribed within routine clinical practice
干预措施: Dymista (Drug)
结局指标
主要结局
Profile of Asian AR patients prescribed with Dymista®
时间窗: The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent
The primary outcome of this non-interventional study is the exploratory description of patient characteristics in regard to demographics, symptoms and allergic rhinitis phenotypes in real life receiving Dymista for the first time.
次要结局
- Effectiveness of Dymista® in Asian AR patients (QOL assessment by VAS)(From day 1 to day 28)
- Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)(From day 1 to day 28)
- Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)(From day 1 to day 28)