NCT03746860已完成不适用
Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,508
- 试验地点
- 1
- 主要终点
- Safety analysis: Number of patients with at least one Adverse Event
研究概览
简要总结
Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months.
详细描述
Condition:
- persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication
- HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent
排除标准
- •Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).
结局指标
主要结局
Safety analysis: Number of patients with at least one Adverse Event
时间窗: 1 year
Number of patients with at least one Adverse Events related to ACARIZAX®.
次要结局
未报告次要终点
研究者
研究点 (1)
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